EN    EN EN  
EN    EN  COMMISSION OF THE E UROPEAN COMMUNITIES 
Brussels, 12.6.2009 
COM(2009) 267 final 
2009/0076 (COD)   
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
concerning the placing on the market  and use of biocidal products  
(Text with EEA relevance) 
 
{SEC(2009) 773} 
{SEC(2009) 774} 
 
  
EN 2   EN EXPLANATORY MEMORANDUM  
1. C ONTEXT OF THE PROPOSAL  
1.1. Grounds for and objectives of the proposal 
Directive 98/8/EC of the European Parlia ment and the Council of 16 February 1998 
concerning the placing of biocidal products on the market (hereinafter 'the Directive') 
establishes a harmonise d regulatory framework for the aut horisation and the placing on the 
market of biocidal products, the mutual rec ognition of these author isations within the 
Community and the establishment at Community level of a positive list of active substances that may be used in biocidal products. In its Article 18(5), the Directive requires the 
Commission to draw up a report se ven years after its entry into force and to submit the report 
to the Council. The report shall address th e implementation of the Directive and the 
functioning up to that date  of the simplified procedures (frame  formulations, low-risk biocidal 
products and commodity substanc es). In accordance with the same provision, the Commission 
may accompany its report, if necessary, by pr oposals for amendment of the Directive.  
The Commission submitted the report on 8 October 2008 (COM(2008)620) and proposed at 
this occasion to extend the review programme, the transitional period, and certain provisions 
on data protection that accompany this period for an additional three years.  
Further to the proposal already presented, and based on the conclu sions of the ‘seven years’ 
report, the present proposal for revision of Di rective 98/8/EC aims to tackle the identified 
weaknesses of the regulatory framework during th e first eight years of its implementation, to 
improve and update certain elements of the syst em and to avoid problems anticipated in the 
future.  
1.2. General context 
The review of the implementation of the Direc tive has indicated that for the evaluation of 
active substances, the simplified procedures provid ed for in the Directive, notably for low-risk 
products (Annex IA to the Directive), have no real effect, and that in addition the data 
requirements and data waiving provisions may be unclear or inconsistently applied or lead to 
a disproportionate burden in some circumstances.  
In addition, although product authorisation has not yet st arted, simplification of the 
procedures concerning the authorisation of bioc idal products in the Member States may be 
beneficial in reducing costs and administrativ e burden for companies and public authorities 
alike. The proposal is seeking to improve the existing regulatory framework, without reducing the high level of protecti on for the environment and human and animal health. 
The proposal also intends to simplify the data pr otection rules, to avoid duplicating vertebrate 
animal studies through mandatory data-sharing, in crease harmonisation of fees systems in the 
Member States, establish rules for parallel trad e of biocidal products, and cover articles or 
materials treated with biocidal products.   
EN 3   EN 1.3. 130Existing provisions in the area of the proposal 
The current regulatory framework for biocidal pr oducts is established by Directive 98/8/EC of 
the European Parliament and the Council of  16 February 1998 concer ning the placing of 
biocidal products on the market and a numbe r of implementing Commission Regulations, in 
particular Commission Regula tion (EC) No 1451/2007 on the se cond phase of the 10-year 
work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament 
and of the Council concerning the placing of biocidal products on the market. .  
1.4. 140Consistency with the other policies and objectives of the Union 
The proposal to revise the Directive takes into  consideration the rece nt revision of EU 
legislation on Chemicals with the adopti on of Regulation (EC) No 1907/2006 (REACH) as 
well as Regulation (EC) No 1272/2008 on clas sification, labelling and packaging of 
substances and mixtures, amending and re pealing Directives 67/548/EEC and 1999/45/EC, 
and amending Regulation (EC) No 1907/2006.  
Due note is also taken of changes in horizontal legislation that affect the biocides regulatory 
framework, such as those related to the proce dures for the exercise of implementing powers 
conferred on the Commission (recent amendmen t of Decision 1999/468/EC) . Furthermore, it 
also takes into consideration the general rule s and the obligations for Member States under 
Regulation (EC) No 765/2008 organising the market  surveillance re lating to the marketing of 
products. 
2. C ONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT  
2.1. Consultation of interested parties 
2.1.1. 211Consultation methods, main sectors target ed and general pro file of respondents 
1. A first consultation workshop was held on 21-22 January 2008 in Ljubljana under the 
auspices of the Slovenian Presidency of the EU. The objective of this workshop was 
to allow a first informal exchange of vi ews between Member States and Commission 
representatives on issues to be addressed in the revision of the Directive. An outline 
of these issues is available at: http://ec.europa.eu/enviro nment/biocides/workshop.htm
 
2. An additional discussion was organised in Bonn on 7-8 April 2008 gathering more 
than 140 representatives of industry, NGOs a nd competent authorit ies. Participants 
debated about the need to streamline the scope of the Directive, among others by 
clarifying border cases and product-types de finition, about the product authorisation 
(e.g. frame formulation, central versus mu tual recognition), about data protection 
rules, as well as simplified or more flexible data requirements approach.  
3. A wider consultation of stakeholders wa s organised through a conference hosted by 
the Commission in Brussels on 23 May 2008 w ith the participation of representatives 
from different sectors of the biocides i ndustry, individual compan ies, consultants and 
national governments. After the participants were informed about the key issues for the revision (presentations  given by Commission officer s) they had the opportunity 
to comment and debate speci fic issues of interest.  
EN 4   EN 4. A targeted stakeholder consultation was also  carried out in the framework of a study 
in preparation of the impact assessment for the revision of the Directive. The 
consultation involved interviews with repres entatives of the industry (including small 
and medium-sized enterprises), national administrations/controlling bodies, environmental protection and consumers'  associations and others, based on 
questionnaires that were previously sent to these stakeholders to prepare the discussions. 
2.1.2. 
212Summary of responses and how they have been taken into account 
1. The consultation conference in Ljubljana  (Commission & Member States) and the 
succeeding conference in Bonn (Member States & Industry) focused on numerous topics of interest for the revision, th e most prominent of those being:  
– the revision of the data protection provi sions and (mandatory) data-sharing;  
– the scope of the regulatory framework (t o include or not the use phase; to add 
provisions about in-situ  generated substan ces and active substance precursors; 
the relationship with other pieces of Comm unity legislation; reduction or not of 
the number of product-types; definition of  a biocidal product and definition of 
placing on the market; how to regulate ar ticles/materials containing biocides); 
– the lack of harmonised provisions in the current Directive regarding product 
authorisation or the procedure to fo llow after the inclusion of an active 
substance in the Community positive list;  
– the possibility to have a single Community  authorisation for biocidal products; 
the role of a centralised Agency for bi ocides; effectiveness of implementation 
and enforcement at Member State level;  
– how to facilitate the (future) mutual recognition procedure;  
– the harmonisation and proportionality of fees charged by Member States, and 
ways to alleviate the financial burden of compliance for SMEs;  
– the performance so far of the Directiv e's simplified procedures (Annex IA; 
Annex IB; prospects for frame formulation concept);  
– the need to clarify the possibility for wa iving data requirements; the use in the 
new instrument of data-waiving provis ions from the REACH Regulation; the 
establishment of a tiered system of data requirements (as was the original idea when the Directive was adopted);  
– specific rules for low-volume or 'niche' market biocides;  
– the need to develop harmonised efficacy requirements.  
Finally, the appropriateness of adopting specif ic provisions on parallel trade; and the 
pros and cons of turning the Directive in to a Regulation were also discussed. The 
Commission has taken into consideration all the - sometimes conflicting - opinions 
expressed by the Member States in the de velopment of its proposal, while trying to  
EN 5   EN identify the best elements amongst them that would contribute to a coherent and 
workable regulatory framework.  
2. During the consultation event in May 2008 in  Brussels (partici pation of various 
stakeholders, mostly industry and enterprises'  representatives), the participants had a 
chance to express their opinions on simplif ied procedures; data requirements; data 
protection and data-sharing; th e procedure for biocidal product authorisation; the fees 
applied by Member States and articles or materials containing biocides.  
In general (although many varying opinions were voiced), the simplified procedures 
of Annex IA and Annex IB were consid ered a failure; the frame formulation 
procedure has not been tried yet but there seems to be some confusion as to how it would work and different expectations as to what it would offer; the data 
requirements are seen as particularly strict  and in some cases as non-proportionate or 
inflexible; the data protection system coul d be further clarified and simplified, and 
certain elements of it should be amended; the industry seems to have come to terms 
with introducing mandatory sharing of verteb rate animal studies; providing for 
harmonised authorisation procedures is seen  as a plus by the industry, and even 
better if a centralised procedure were adopted; the fees or  at least the f ee systems will 
need to be harmonised; and a solution shoul d be found for articles  or materials that 
are containing biocidal products , in particular those arti cles or materials imported 
from third countries. All these concerns were taken into consideration and are 
reflected in the proposal. 
3. The targeted consultation served mos tly the purpose of obt aining the necessary 
quantitative/qualitative information for preparing the impact assessment report 
presented in support to this proposal. It c overed all the issues discussed with the 
Member States in Ljubljana,  in Bonn and with the stake holders in Brussels and the 
responses were mostly the same with th ose expressed in the three consultation 
events. 
An open consultation was conducted ove r the internet from 15/11/2006 to 
15/01/2007. The Commission received 250 response(s). The results of the open 
internet consultation were incorporated in the Commission report on the impacts of the implementation of Directive 98/8/EC available at: http://ec.europa.eu/environment/biocides/study.htm
 . 
2.2. Collection and use of expertise 
To support this proposal, several studies we re carried out by exte rnal contractors: 
– a study to assess the impact of the revisi on of Directive 98/8/ EC concerning the 
placing of biocidal products on the market; 
– a study on impacts of possible measures to ma nage articles or materials treated with 
biocides, in particular when imported;  
– a study on the impacts of the implementa tion of Directive 98/8/EC on biocidal 
products; and   
EN 6   EN – a study on the assessment of different options  to address risks from the use phase of 
biocides. 
These studies were evaluated by the Comm ission and taken into consideration while 
preparing the current proposal. In  particular, the study to assess the impact of the revision of 
Directive 98/8/EC concerning the placing of bi ocidal products on the market evaluated the 
economic, social and environmental impacts of the different policy options. The conclusions 
of this study are directly refl ected in the impact assessment de scribed in the following section. 
More information on the st udies is available at: 
http://ec.europa.eu/environment/biocides/study.htm  and 
http://ec.europa.eu/enviro nment/biocides/revision.htm . 
2.3. 230Impact assessment 
The Impact Assessment addresses five policy issues that require action: 
POLICY ISSUE 1: SCOPE – Unchanged policy; 
– Extend scope to cover processing ai ds and food contact materials; 
– Extend scope to cover treated materials containing biocides. 
The assessment concluded that including materi als containing biocides in the scope of the 
Directive would significantly increase the co sts to industry. However, although the equal 
treatment of industry, and environmental and huma n health benefits are difficult to quantify, 
they are likely to be significan t. Including, in particular food pr ocessing aids in the scope of 
the Directive is likely to resu lt in a complicated process of  authorisation under two legal 
frameworks which may lead to some duplication of efforts. The related costs are likely to 
outweigh the limited benefits re sulting from better control of  environmental impacts and 
greater regulatory certainty. 
POLICY ISSUE 2: PRODUCT AUTHORISATION 
– Unchanged policy; 
– Strengthening of mutual recognition; 
– Single Member State authorisation; 
– Community authorisation. 
The assessment concluded that a Community authorisation or a single Member State 
authorisation would be the most efficien t systems and would provide incentives for 
innovation of products based on new active substa nces/low-risk products . However, as the 
Member States have expressed significant conc erns about a full centralisation of the product 
authorisation or a single Member State authorisa tion due to reduced role for the other Member 
States, a combination of the Community au thorisation for certain  products with the 
strengthening of the mutual re cognition process for other products appears to be the most 
acceptable solution.  
EN 7   EN POLICY ISSUE 3: DATA-SHARING 
– Unchanged policy; 
– Mandatory sharing of vertebrate animal  test data for pr oduct authorisation; 
– Mandatory sharing of vertebrate animal te st data for active substance approval and 
for product authorisation. 
The assessment concluded that mandatory data-s haring for active substance approval and for 
product authorisation imp lies the highest total cost savings to applicants, possibly the highest 
number of safer products remaining on the market and the highest number of animals saved.  
POLICY ISSUE 4: DATA REQUIREMENTS – Unchanged policy; 
– Rewording provisions concerning data waivi ng and the use of existing information; 
– Reformulating the system for low-risk substances/products. 
The policy options address two types of problems: high data requirements and low 
attractiveness of the simplified procedures, in particular for low-risk and basic substances. 
The assessment concluded that all the options have significant potential to reduce costs for 
industry and that the last two options woul d also significantly reduce the numbers of 
vertebrate animal tests. In order to meet th e objectives of the revision, the best option seems 
to be a combination of data waiving with the use of existing information and a new approach 
to low-risk biocidal products. 
POLICY ISSUE 5: FEES CHARGED BY MEMBER STATES FOR CARRYING OUT THE 
PROCEDURES OF THE DIRECTIVE 
– Unchanged policy; 
– Partially harmonised fee structure; 
– Centralised fee system; 
– Specific provisions for SMEs. 
The assessment concluded that a partially harmonised fee structure may encourage the 
development of more new active substances and the retention of more existing active 
substances. It should also reduce the costs for the approval of active substances for several 
product types. The last option will make the procedure less costly for SMEs, which should 
help them to stay on the market. A fully centralised fee system would raise questions 
concerning the subsidiarity principle as it w ould transfer the competences over setting the 
levels of fees from the Memb er States to the Community. 
The Commission carried out an impact assessm ent which is attached to this proposal.  
EN 8   EN 3. L EGAL ELEMENTS OF THE PROPOSAL  
3.1. 305Summary of the proposed action 
The revision of the Biocides Directive intends  to remedy a number of  weaknesses that were 
identified during the first eight  years of its implem entation, to anticipate problems with the 
upcoming authorisation and mutual recognitio n procedure, and to update and adapt the 
instrument to recent policy developments. 
First, the Directive is turned into a Regulat ion. As a result, there will be no need for a 
transposition period or for nationa l transposition measures, which is also expected to ensure 
more harmonised implementation of the regu latory framework in the Member States. 
Among the proposed amendments of the scope, par ticularly relevant are the extension of the 
scope to biocides in materials that might come  into contact with food and the new provisions 
on articles or materials cont aining biocidal products.  
In particular with regard to th e latter, under the current  situation, if an arti cle is treated in the 
EU then only a biocidal product that is authoris ed for that purpose may be used. However, if 
the article is treated with a biocidal product outside the EU and then imported, there is no 
control over the substance it may incorporate. Th is could represent risk s for human health or 
for the environment if active substances that are not assessed or even banned in the EU are 
incorporated in such goods whic h are then imported into the EU. In addition, this situation is 
discriminatory to the EU industry, and could lead to the production of  treated articles or 
materials being moved out of the EU in order to circumvent restrictions on certain substances. 
As part of the revision of the Biocides Directiv e, it is proposed that all articles or materials 
must be treated only with biocidal products auth orised for that purpose in at least one Member 
State. 
Labelling requirements are accompanying the provi sion on articles or materials treated with 
biocides. These have two objectives: to inform consumers that the article was treated with a 
biocidal product; and to alert competent and/or  customs authorities in the Member States and 
trigger any existing inspection provisions ai med at ensuring compliance. The labelling 
provisions apply equally to EU  and non EU manufacturers.  
The proposed Regulation provides also for harm onised procedures for the authorisation of 
biocidal products, an element that is signifi cantly underdeveloped in th e current Directive. 
The provisions regarding mutual recognition of au thorisations are rework ed and clarified, in 
particular the resolution of di sputes between Member States, or between Member States and 
applicants. This is expected to contri bute to a smooth functioning of the upcoming 
authorisations of biocidal products. 
Apart from the case of authorisations gr anted by the Member States, a centralised 
authorisation system is proposed. This will be available for products identified as low-risk - 
without having to go through a se parate evaluation of the activ e substance first- and for 
products containing new active su bstances. The latter is expect ed to promote research and 
innovation in the biocides field.  
The technical and scientific tasks relevant to th is centralised system will be carried out by the 
European Chemicals Agency (ECHA). To this end, the proposal incorp orates the necessary 
provisions governing the procedural and orga nisational details. In addition, ECHA will  
EN 9   EN undertake the coordination of or ganisational and technical task s for the evaluation of all 
applications for inclusion of active substances in Annex I (the Community positive list for active substances) which were until now attribut ed to the Commission Joint Research Centre.  
The simplified procedures involving the current Annex IA and IB are re pealed, as very little 
or no use of them has been made so far.  The simplified proced ure involving frame 
formulations - which has not yet been put into pr actice - is modified so as to allow, within a 
group of products belonging to the same frame formulation, the replacement of any non-active ingredient by other non-active ingredients. Currently, this is restricted to pigments, 
dyes, and perfumes. The Regulation will also incorporate rules governing the modalities and 
conditions to apply for modifications to authorisations that are already granted. 
The rules on comparative assessment are also m odified, as the current system does not seem 
sufficiently clear - for instance, it is rather  problematic to apply comparative assessment 
during the review programme, where all ex isting substances are being evaluated. The 
proposed system comprises a fi rst stage where active substan ces that even though overall 
acceptable still give rise to concern are listed in  Annex I, but are also flagged for substitution. 
Biocidal products containing th ese active substances may be compared with others that are 
available on the market for the same or simila r use pattern, and if they  present significantly 
higher risk than those, their au thorisations are refused or can celled at Member State level. 
In line with recent policy developments in RE ACH and the draft Regulation on the placing of 
plant protection products on the market, sharing of  vertebrate animal studies in exchange for 
equitable compensation becomes mandatory. This is  expected to save costs and animal lives 
by prohibiting the duplication of these studies. 
The data protection system is significantly si mplified, without cutting back on any acquired 
rights under the current system. It also grants pr otection to data submitt ed after the inclusion 
of the active substance in Anne x I (mainly during product authoris ation): these st udies are not 
protected by the current legisl ation. The proposed data protecti on system also covers the case 
of newly generated studies that, contrary to the legislator's intention, do not benefit from data 
protection because certain Member States requ ired their submission for the purposes of 
national authorisation during the transitional pe riod (only data submitted for the first time in 
support of the first inclusion of  the active substance are prot ected by the current system). 
The data requirements of the Directive are mo dified. First, the prin ciple of proposing and 
accepting adaptations to the data requirements is  formalised and Member States have to 
inform and if possible assist the applicants with their adaptation requests. Second, the grounds 
for data waiving provided for in REACH will a pply also for the proposed Regulation. Third, 
the core data requirements are modified an d certain long-term animal studies are only 
required when necessary - these happen to be the most costly data requirements, in terms of lives of test animals and in terms of money. 
The confidentiality provisions are slightly modi fied and aligned with those of REACH. This 
is to facilitate their application by ECHA, whic h would otherwise have to apply two different 
sets of confidentiality rule s in its everyday operations. 
For the purpose of facilitating th e movement of biocidal produc ts in the EU territory, the 
proposal provides for specific parallel trade rule s: authorised biocidal products that have the 
same use, contain the same active substance and have essentially identical composition to  
EN 10   EN products authorised in another Member State may be placed on the market of that other 
Member State via a simplified administrative procedure. 
Finally, the proposal provides for a number of tr ansitional measures to facilitate the transition 
from the system of the Directive to that of  the draft Regulation, to  introduce ECHA into the 
biocides regulatory framework, and to safeguard  any acquired rights under  the current system. 
3.2. 310Legal basis 
Article 95 of TEC.  
3.3. 329Subsidiarity principle 
The purpose of this Regulation is to facilitate the free movement of bi ocidal products within 
the Community. In order to ensure the functi oning of the internal market with biocidal 
products, it is necessary to harmonise the conditio ns of their placing on the market at the level 
of the Community.  
Individual measures of Member States stemming  from the different levels of protection could 
result in obstacles to trade in  biocidal products. This could compromise the achievement of 
objectives related to the internal market. The Community is, therefore, better placed to take action with regards to the condi tions of placing on the market and use of biocidal products. 
The subsidiarity principle was also closely c onsidered when deciding on the distribution of 
tasks between the competent authorities of Member States, the Agency and the Commission, in particular with respect to the authorisation of bi ocidal products. 
3.4. Proportionality principle 
The proposal complies with the proportionali ty principle for the following reason(s). 
The proposed Regulation aims to harmonise th e conditions for placing biocidal products on 
the market but with respect to the majority of  biocidal products it leaves it to the Member 
States to authorise these products in accord ance with these conditions. The centralised 
procedure in which the Commissi on grants a Community authorisa tion will be restricted to 
two categories of biocidal products: products based on new active substances and low-risk 
biocidal products. For these cate gories of biocidal products centralisation is justified because 
of its positive impact on innovation and inst ant access to the entir e Community market. 
The proportionality principle was also respecte d with respect to the fees. The Commission 
will adopt another Regulation setting out a harmonised structure for fees but the decision on the amount of the fees will remain within  the competence of the Member States. 
Furthermore, the proposed Regulation does not go further than what is necessary with respect 
to its scope and the admi nistrative burden on the industry as well as the compet ent authorities. 
In fact, the administrative and financial burden on th e industry and the co mpetent authorities 
will be reduced compared to Directive 98/8/EC because of the following reasons: 
– the provision of strict deadlines for each  procedural step will increase the 
predictability and facilitate the acces s of biocidal products to the market;  
EN 11   EN – the centralised authorisa tion will save time and cost s for both the industry and 
competent authorities;  
– the possibility of a mutual recognition in  parallel will provide for a closer 
cooperation among the Member States conc erning the evaluation of a biocidal 
product while saving financial and human resources; 
– the mandatory data sharing with respect to vertebrate animal data will save the costs 
for the industry and avoid repeated eval uating of the same data by the competent 
authorities. 
3.5. Choice of instruments 
Proposed instruments: Regulation. 
Other means would not be adequate for the following reason(s). The current regulatory framewor k for the placing on the market  of biocidal products is 
Directive 98/8/EC. The Commission - in lin e with recent proposals concerning the plant 
protection products legislation and general chemicals legislat ion (the REACH Regulation and 
the Regulation on classification, labelling and packaging of substances and mixtures) - is 
proposing to replace that Directive with a Regul ation. This will eliminate the need for a 
transitional period and will advance the implem entation of urgently needed provisions by 
approximately two years. A Regulation will also  ensure the uniform application of the new 
instrument throughout the EU, in particular the procedures and deadlines for authorisation of 
biocidal products and mutual recognition of those authorisations. Differences in the 
transposition of measures and/or the implemen tation would have very serious consequences 
for the functioning of the internal market in biocidal products. 
The choice of the legal instrument will also reduce the administrative burden and ensure the 
clarity for the industry. 
4. B
UDGETARY IMPLICATION  
The proposal will have budgetary implications as  there is a need to support the European 
Chemicals Agency (the Agency) in taking up th e additional tasks related to the assessment 
and inclusion of active substances  used in biocidal products in  Annex I of the Regulation and 
the centralised authorisation of  certain biocidal products. Th e Agency will receive specific 
fees from applicants for certain of these ac tivities as well as an annual fee on products 
centrally authorised by the Community. The revenue from the fees will have to be supplemented by a subsidy from the Community. It is, however, expected that this support 
from the Community will be limited in time as the activities of the Agency should be self-
funding through fee revenues after a number of years. Detailed rules on the budget of the 
Agency and its implementation are already laid down in REACH Regulation (EC) No. 
1907/2006. These rules shall apply accordingl y in the context of this Regulation.  
EN 12   EN 5. A DDITIONAL INFORMATION  
5.1. 510Simplification 
The proposal provides for simplification of le gislation, simplificatio n of administrative 
procedures for public authorities (EU or  national), and for private parties. 
Apart from the obvious economy of dispensing  with transposition measures, transposition 
periods and transposition confor mity controls that is achieved by replacing the current 
Directive with a Regulation, the proposal clarifie s in much greater detail than in the present 
text the procedures to be followed for granti ng authorisations by the Member States and the 
procedures for mutual recogniti on of those authorisations.  
In particular, the acceptable grounds for oppos ing mutual recognition are made clear and 
procedural steps are provided for the resolution of disputes. 
In addition, the grounds for waivi ng data requirements are set out in more detail, enhancing 
legal certainty for the applicants. In the current  system, while the prin ciple of waiving data 
requirements is recognised, little is provided as conditions for implementing the principle. As a result, Member States are sometimes reluctant to  allow that certain studies listed in the core 
data set need not be submitted by the applicant as the safety of a substance is sufficiently established by other available information.  
The data protection provisions are simplified and better aligne d with the objectives of the 
Community policy (recovery of costs - pr otection for newly generated data). 
Lastly, the establishment of a centralised system for the authorisation of certain products is an 
obvious simplification as the products concerned w ill not need individual authorisation in all 
or some of the 27 Member States.  
The Member States competent authorities w ill have a more harmonised framework for 
granting authorisations (e.g. harmonised content of an aut horisation document). They will 
also have specific deadlines and procedures for all the tasks related to authorisation and 
mutual recognition. 
With the handling of the procedure for the evaluation of active substances by ECHA there 
will be greater transparency, co-ordination and efficiency of the process compared to the 
current system. This will among others avoid the same active substance being evaluated in parallel by two differe nt Member States.  
The proposal foresees that Member States will  have a common structure on the basis of which 
they can rationally devel op their fees' systems. 
Enterprises supporting the placing on the market  of a low-risk product or a product containing 
a new active substance will be able to obtain only one (Community) authorisation valid for 
the whole EU territory. Consequently, the Member States will not need to carry out an evaluation as those products will be approved via centralised authorisations. There will also 
be no need for mutual recognition or multiple pr ovisional authorisation procedures for these 
products, as those will be handl ed at Community level by ECHA. 
Enterprises will now have to consult only one lega l text that applies in the EU instead of 27 
national transposition instruments.  
EN 13   EN Authorisation and mutual rec ognition procedures are better defined and predictable and 
specific deadlines are added.  
The legal certainty is increased with regard to  the protection afforded to studies submitted in 
support of an application. 
The proposal is included in the Commi ssion's rolling programme for up-date and 
simplification of the acquis communautaire a nd its Work and Legislative Programme under 
the reference COM(2007) 640. 
5.2. 520Repeal of existing legislation 
The adoption of the proposal will lead to the repeal of existing legi slation, in particular 
Directive 98/8/EC. 
5.3. Review/revision/sunset clause 
The proposal includes a review clause.  
5.4. 540Recasting 
The proposal does not involve recasting.   
5.5. 560European Economic Area 
The proposed act concerns an EEA matter a nd should therefore extend to the European 
Economic Area. 
EN 14   EN 2009/0076 (COD) 
Proposal for a 
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 
concerning the placing on the market  and use of biocidal products  
(Text with EEA relevance) 
THE EUROPEAN PARLIAMENT AND THE CO UNCIL OF THE EUROPEAN UNION, 
Having regard to the Treaty esta blishing the European Communit y, and in particular Article 
95 thereof, 
Having regard to the proposal from the Commission1, 
Having regard to the opinion of the Eu ropean Economic and Social Committee2, 
Having regard to the opinion of  the Committee of the Regions3, 
Acting in accordance with the procedure laid down in Article 251 of the Treaty4, 
Whereas: (1) Biocidal products are necessary for the c ontrol of organisms that are harmful to human 
or animal health and for the control of or ganisms that cause damage to natural or 
manufactured products. However, biocidal products can pose risks to humans, animals 
and the environment due to their intrinsi c properties and associated use patterns. 
(2) Biocidal products should not be placed on the market or used unless they comply with 
the authorisation granted in accordance with this Regulation.  
(3) The purpose of this Regulation is to incr ease the free movement of biocidal products 
within the Community. In order to remove as far as possible obstacles to trade in 
biocidal products stemming from the differe nt levels of protection in the Member 
States, harmonised rules should be laid down for the approval of active substances and 
the placing on the market and use of bi ocidal products, including the rules on the 
mutual recognition of authorisat ions and on parallel trade.  
(4) Rules concerning the placing on the market  of biocidal products in the Community 
were initially adopted in Di rective 98/8/EC of the Europ ean Parliament and of the 
Council of 16 February 1998 conc erning the placing of bi ocidal products on the 
                                                
 
1 OJ C , , p. . 
2 OJ C , , p. . 
3 OJ C , , p. . 
4 OJ C , , p. .  
EN 15   EN market5. It is necessary to adapt that system on the basis of a report on the first seven 
years of its implementation submitted by the Commission to the European Parliament and the Council
6, which analyses problems and weaknesses of that Directive. 
(5) Taking into account the main adaptations which are introduced in the existing 
regulatory system, a Regulation is the appropriate legal inst rument to replace Directive 
98/8/EC as it imposes clear and detailed ru les which do not give room for diverging 
transposition by Member States. Moreove r, a Regulation ensures that legal 
requirements are implemented at th e same time throughout the Community. 
(6) A difference should be made between exis ting active substances which were on the 
market in biocidal products on 14 May 2000 and new active substances which were not yet on the market in biocidal products by this date. That date was initially set in 
Directive 98/8/EC as the date by which that  Directive had to be transposed into 
national legislation. That date made a diffe rence between substan ces which were on 
the market on that date and those which we re not. A work programme is carried out 
for the review of all existing substances wi th view to their incl usion in Annex I to 
Directive 98/8/EC. During that review , biocidal products containing existing 
substances can continue being placed on the market in order to prevent a situation 
where no biocidal products would be availa ble on the market. New active substances 
should be reviewed before biocidal produc ts containing them could be placed on the 
market so as to ensure that only safe new products could be placed on the market. 
(7) During the work programme, and at most  up until the decision on inclusion of the 
active substance in Annex I to Directive 98/8/EC, Member States may temporarily authorise biocidal products not  complying with the provisio ns of this Regulation under 
certain conditions. Following th e decision on inclusion, Me mber States should grant, 
cancel or modify authorisations in  accordance with this Regulation. 
(8) In order to ensure legal certainty, it is necessary to establish a Community list of active 
substances permitted for use in biocidal products. A procedure should be laid down for assessing whether or not an active substa nce can be entered in the Community list. 
The information that interested parties shoul d submit in support of an inclusion of an 
active substance in the Commun ity list should be specified.  
(9) The risks associated with the producti on, use and disposal of a chemically active 
substance and materials and articles treated wi th it are to be asse ssed and managed in a 
similar way as they are in Regulation (EC) No 1907/2006 of  the European Parliament 
and of the Council of 18 December 2006 c oncerning the Registration, Evaluation, 
Authorisation and Restricti on of Chemicals (REACH), establishing a European 
Chemicals Agency, amending Directive 1999/ 45/EC and repealing Council Regulation 
(EEC) No 793/93 and Commission Regulatio n (EC) No 1488/94 as well as Council 
Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 
93/105/EC and 2000/21/EC
7. 
(10) With view to achieving a high level of  environmental and human health protection, 
active substances with the worst hazard profiles should not be approved for use in 
                                                 
5 OJ L 123, 24. 04. 1998, p.1. 
6 COM(2008)620  
7 OJ L 396, 30.12.2006, p. 1  
EN 16   EN biocidal products except in specific situa tions. These should include situations when 
the approval is justified because of a neglig ible exposure of humans to the substance, 
public health reasons or disproportionate negative impacts of a possible non-inclusion 
provided no alternatives exist.  
(11) In order to prevent the use of active s ubstances with the worst hazard profiles, in 
particular when their use is not author ised under Regulation (EC) No XXX/2009 of 
the European Parliament and of the Council of ..... 2009 concerning the placing of 
plant protection products on the market a nd repealing Council Directives 79/117/EEC 
and 91/414/EEC8, it is appropriate to restrict thei r approval to situations when the 
exposure of humans to the substance is negl igible or the substance is necessary for 
public health reasons. 
(12) The active substances in the Community list should be regularly  examined to take 
account of developments in science and technology. Where there are serious 
indications that an active substance used in biocidal products may pose higher risk 
than previously thought, the Commission should  be able to review an inclusion of the 
active substance.  
(13) Active substances can, on basis of thei r intrinsic hazardous prope rties, be designated 
as candidates for substitution with other ac tive substances, whenever such substances 
considered as efficient towards the target ed harmful organisms become available in 
sufficient variety to avoid the development of resistances amongst harmful organisms. 
In order to allow for a regular examination of substances identified as candidates for 
substitution, the inclusion period for these s ubstances should not, even in the case of 
renewal, exceed ten years. Furthermore, the identification of substances which are considered as candidates for substitution shou ld be considered as a first step of a 
comparative assessment. 
(14) In course of the authoris ation or renewal of biocidal product authorisations, it should 
be possible to compare two or more biocidal  products with regard  to risks posed by 
them and benefits accrued through their us e. As a result of such a comparative 
assessment, authorised biocid al products containi ng active substanc es indicated as 
candidates for substitution could be replaced wi th others that present significantly less 
risk to health or to the environment and where there are no significant adverse 
economic or practical impacts. Appropriate phase-out periods shoul d be foreseen in 
such cases. 
(15) In order to avoid unnecessary administra tive and financial burde n for the industry as 
well as competent authorities, a full in-depth evaluation of an application to renew the inclusion of an active substa nce in the Community list or the authorisation should only 
be carried out if the competent authority that  was responsible for the initial evaluation 
decides so on basis of the available information.  
(16) There is a need to ensure effective c oordination and management  of the technical, 
scientific and administrative aspects of this Regulation at Community level. The 
European Chemicals Agency set up under Regulation (EC) No 1907/2006 should carry out specified tasks with regard to the evaluation of active subs tances as well as 
                                                
 
8 OJ L , , p. .  
EN 17   EN the authorisation of certain categories of biocidal product s and related tasks in the 
Community territory. Consequently, a Biocidal Products Committee should be 
established within the Agency to carry out  the tasks attributed to the European 
Chemicals Agency by this Regulation. 
(17) It is recognised that bioc idal products intended to be used  not only for purposes of this 
Regulation but also in connection with medical  devices, such as disinfectants used for 
the disinfection of surfaces in hospitals as well as medical devices, may pose risks 
different from those covered by this Regula tion. Therefore, it s hould be required that 
such biocidal products comply, in addition to the requirements laid down in this 
Regulation, with the relevant essential re quirements of Council Directive 90/385/EEC 
of 20 June 1990 on the approximation of the la ws of the Member States relating to 
active implantable medical devices9, Council Directive 93/42/EEC of 14 June 1993 
concerning medical devices10 or Directive 98/79/EC of th e European Parliament and 
of the Council of 27 October 1998 on in  vitro diagnostic medical devices11. 
(18) As the costs of the application of this  Regulation to food or feedingstuffs used for 
biocidal purposes would be disproportiona te to the benefits thereof, food and 
feedingstuffs used for biocidal purposes should not be covere d by this Regulation. 
Furthermore, the safety of food and feedings tuffs is subject to Co mmunity legislation, 
in particular Regulation (EC) No 178/2002 of the European Parliament and of the 
Council of 28 January 2002 layi ng down the general princi ples and requirements of 
food law, establishing th e European Food Safety Au thority and laying down 
procedures in matters of food safety12. 
(19) Processing aids are cove red by existing Community legisl ation in particular, Council 
Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the 
Member States concerning food additives aut horized for use in foodstuffs intended for 
human consumption13 and Regulation (EC) No 1831/2003 of the European Parliament 
and of the Council of 22 September 2003 on additives for use in animal nutrition14. 
Therefore, it is appropriate to exclude them from the scope of this Regulation. 
(20) As products used for the preservation of food or feedstocks by th e control of harmful 
organisms, previously covered by product type 20, are covered by Council Directive 
89/107/EEC and Regulation (EC) No 1831/2003 of  the European Parliament and of 
the Council, it is not appropriate to maintain this product type. 
(21) As the International Convention for the Control and Management of Ships' Ballast 
Water and Sediments provides for an effectiv e assessment of the risks posed by ballast 
water management systems, the final approva l and subsequent type approval of such 
systems should be considered equivalent to the product authoris ation required under 
this Regulation. 
                                                 
9 OJ L 189, 20.7.1990, p. 17. 
10 OJ L 169, 12.7.1993, p. 1. 
11 OJ L 331, 7.12.1998, p. 1. 
12 OJ L 31, 1.2.2002, p. 1 
13 OJ L 40, 11.2.1989, p. 27 
14 OJ L 268, 18.10.2003, p. 29  
EN 18   EN (22) To take account of the specific nature of  some biocidal products and the low level of 
risk associated with their proposed use, a nd to encourage the development of biocidal 
products containing new active substances, it is appropriate to provide for a 
Community authorisatio n of those products. 
(23) In order to ensure that on ly biocidal products that comply  with the relevant provisions 
of this Regulation are placed on the market, biocidal products should be subject to 
authorisation either by competent authoritie s for placing on the market or use in a 
territory of a Member State,  or a part of it, or by the Commission for placing on the 
market or use in the Community.  
(24) In order to facilitate access to the intern al market and to avoid the additional costs and 
time involved in obtaining sepa rate national author isations in separate Member States, 
the Commission, taking into account th e experience with the provisions on 
Community authorisations, may decide to extend the scope of the Community 
authorisation procedure to other biocidal products.  
(25) To ensure a harmonised app lication of the low-risk criteria  by competent authorities, it 
is necessary to specify those criteria in the Regulation as far as possible. The criteria 
should be based on the hazard characteristics of the biocidal produc ts and the exposure 
to the product associated with  its use. The use of low-risk  biocidal products should not 
lead to a high risk of developi ng resistance in target organisms. 
(26) In order to encourage the use of low -risk biocidal products with more favourable 
environmental or human health profile compar ed to other biocidal products, it should 
be allowed to authorise low-risk biocidal products without prior approval of the active 
substances contained therein. 
(27) In view of the provisions on low-risk biocidal products in th is Regulation, it seems 
appropriate to exempt active substances  contained in those products from the 
registration obligations under Regulation (EC) 1907/2006. This is, in particular, 
necessary because these substances do not fulf il the conditions in Ar ticle 15(2) of that 
Regulation.  
(28) It is necessary to provide common principles for th e evaluation and au thorisation of 
biocidal products to ensure a harmonis ed approach by competent authorities. 
(29) In order to evaluate the risks that w ould arise from the proposed uses of biocidal 
products, it is appropriate that the applicants submit dossiers which contain the 
necessary information. Defining a data set for active substances and for biocidal 
products in which they are contained is neces sary so as to assist both the applicants 
seeking authorisation and competent authori ties carrying out the ev aluation to decide 
on the authorisation.  
(30) In the light of the divers ity of both the active substances  and the biocidal products, the 
data and test requirements should suit th e individual circumstances and allow an 
overall risk assessment. Therefore, an app licant should be able to  request adaptations 
of the data requirements, as appropriate, including the waiving of data requirements 
which are not necessary or impossible to submit in view of the nature or the proposed uses of the product. A pplicants should provide the appr opriate technical and scientific 
justification to s upport their requests.  
EN 19   EN (31) In order to ensure that the applicant can effectively exer cise his right to request an 
adaptation of the data requirements, the competent authorities should inform the 
applicant about this possibility and the gr ounds on which such request could be made. 
Furthermore, in order to facilitate the prepar ation of the request, in particular by small- 
and medium-sized enterprises (SMEs), th e competent authority should assist the 
applicant, where possible, in  preparing such a request. 
(32) In order to facil itate access to the market  of biocidal products belonging to one group 
of products, it should be possible to author ise such groups of biocidal products with 
similar uses and allow for limited variations with regard to the reference biocidal product provided that those changes do not aff ect the level of the risk and the efficacy 
of the products. 
(33) When biocidal products are being author ised, it is necessary to ensure that, when 
properly used for the purpose intended, they are sufficiently effective and have no unacceptable effect on the target organisms su ch as resistance, and, in the case of 
vertebrate animals, unnecessary suffering and pain, and have, in the light of current 
scientific and technical knowledge, no unaccepta ble effect on the environment and on 
human or animal health. When deciding whether a biocidal product should be 
authorised, due considerati on should be given to the benefits from its use.  
(34) In order to a void duplication of the evaluation procedures and to ensure free 
movement of biocidal products, as well as of  materials and articles treated with them, 
within the Community, procedures should be es tablished to ensure that authorisations 
of products granted in one Me mber States are recognised in  all other Member States.  
(35) Specific provisions should lay down pr ocedures to ensure the smooth operation of 
mutual recognition of authorisations granted by Member States, and in particular the 
resolution of any disagreements without undue delay. 
(36) In order to enable Member States to co -operate in the evaluati on of biocidal products 
and to facilitate the access of biocidal produc ts to the market, it should be possible to 
launch the process of the mutual recognition together with the application for the first authorisation. 
(37) There is a need to provide for a dispute settlement mechanism at Community level to 
ensure an effective functioning of mutual r ecognition. If a competent authority refuses 
to mutually recognise an au thorisation or proposes to restrict it, the Commission 
should be empowered to take a decision. In case of technical or scientific questions, 
the Commission may consult the Agency before preparing the decision. 
(38) While envisaging harmonised provisions fo r all biocidal product types, including those 
intended to control vertebrates, the actual use of such product types might give rise to 
concern. Therefore, Member States should be  allowed to derogate from the principle 
of mutual recognition for biocidal products falling under certain particular types of 
biocides when intended to c ontrol particular kinds of vert ebrates, in so far as such 
derogations are justified a nd do not jeopardise the pu rpose of this Regulation 
regarding an appropriate level of protection of the internal market. 
(39) In order to faci litate the functioning of the aut horisation and mutual recognition 
procedures, it is appropriate to establish a system for the mutual exchange of  
EN 20   EN information and Member States, the Co mmission and the Agency should make 
available to each other on request the pa rticulars and scientific documentation 
submitted in connection with applications for authorisation of biocidal products. 
(40) If the use of a biocidal product is in th e interest of a Member State, but there is no 
applicant interested in the placing of the ma rket of such product in the Member State, 
pest control bodies and other professional orga nisations should be allowed to apply for 
an authorisation. In the case th ey are granted an authorisa tion, they should possess the 
same rights and obligations as any other authorisation holder. 
(41) In order to take account of the scientific and technical developments as well as the 
needs of the authorisation holders, it s hould be specified under which conditions 
authorisations can be cancelled, reviewed or amended. Provisions on the notification 
and exchange of information which may affect  the authorisations should be set out so 
as to enable the competent authorities a nd the Commission to take  appropriate action.  
(42) In the event of an unfor eseen danger threatening public  health or the environment 
which cannot be contained by other means, it should be possible for Member States to 
authorise, for a limited period of time, bioc idal products which do not comply with the 
requirements laid down in this Regulation.  
(43) In order to encourage th e development of new active subs tances, the proc edure for the 
evaluation of a newly developed active substa nce should not prevent Member States or 
the Community from authorising, for a limited period of time, biocidal products containing that active substance before the latter is entered in Annex I, provided that a 
dossier meeting all requirements has been submitted and it is believed that the active substance and the biocidal product sa tisfy the conditions set for them.  
(44) In order to encourage th e research and development in active substances and biocidal 
products, it is necessary to establish rules under which una uthorised biocidal products 
or active substances may be placed on the market for the purposes of research and development.  
(45) In view of the benefits for the internal market and for the consumer, it is desirable to 
establish harmonised rules for parallel trade of  substantially identi cal biocidal products 
that are authorised in different Member States. 
(46) For purposes of the protection of human a nd animal health and of the environment, as 
well as for the non-discrimination between ar ticles or materials originating in the 
Community and articles or materials imported from third countries, all treated articles 
or materials placed on the internal market  should contain only authorised biocidal 
products. 
(47) For the purpose of enabling consumers to  make informed choices and facilitating the 
enforcement of this Regulation by competent au thorities, articles or materials treated 
with biocidal products shoul d be appropriately labelled. 
(48) Applicants that have in vested in supporting the inclusi on of an active substance in 
Annex I or in the authorisation of a biocidal product in accordance with the provisions of this Regulation should be able to rec over part of their investment by receiving 
equitable compensation whenever use of proprietary information which they submitted  
EN 21   EN in support of such inclusions or authorisati ons is made for the benefit of subsequent 
applicants.  
(49) In view of ensuring that all propri etary information submitted in support of an 
inclusion of an active substance or an auth orisation of a biocidal  product is protected 
from the moment of its submission and to prevent situations where some information is without protection, the provision on information prot ection periods should also 
apply to information submitted for the purposes of Directive 98/8/EC. 
(50) In order to encourage the development of  new active substances and biocidal products 
containing them, it is necessary to provide fo r a period of protection with respect to the 
proprietary information submitted in support of  the inclusion of active substances or 
authorisations of products which is longer th an the period of protection for information 
concerning existing active substan ces and products containing them. 
(51) It is essential to minimise the number of  tests on animals and to ensure that testing 
should be made dependent on the purpose a nd use of a product. Applicants should 
share, and not duplicate, vertebrate animal studies in exchange for equitable compensation. In absence of an agreement on sharing of vertebrate animal studies 
between the data owner and the prospectiv e applicant, the Agen cy should allow the 
use of the studies by the prospective appli cant without prejudice to the decision on the 
compensation made by national courts. A Co mmunity register listing the contact 
details of the owners of such studies should be  established and put at  the disposal of all 
authorities to inform prospective applicants. 
(52) The generation of information by alte rnative means not involving tests on animals 
which are equivalent to pres cribed tests and test methods  should also be encouraged. 
In addition, the adaptation of  data requirements should be used to prevent unnecessary 
costs related to testing. 
(53) In order to ensure that the requirements laid down in respect of authorised biocidal 
products are satisfied when they are placed  on the market, the Member States should 
take measures for appropriate c ontrol and inspection arrangements. 
(54) It is necessary to provide for the e ffective communication of information on risks 
resulting from biocidal products and risk  management measures as it forms an 
essential part of the system established by this Regulation. While facilitating access to 
information, competent authorities, the Agency and the Commission should respect 
the principle of confidentiality and avoid any disclosure of information which could be harmful for the commercial intere sts of the person concerned. 
(55) In order to increase the efficiency of monitoring and cont rol, and to provide 
information relevant for addressing the risks of biocidal products , producers, importers 
and professional users should be required to keep reco rds of the products they 
produce, place on the market or use. The Commission should adopt implementing rules on data collection, tr ansmission and processing. 
(56) In order to facilitate th e exchange of information betw een competent authorities, the 
Agency and the Commission, the Community Re gister for Biocidal Products should be 
established.  
EN 22   EN (57) It is necessary to specify that pr ovisions concerning the Agency laid down in 
Regulation (EC) No 1907/2006 s hould apply accordingly in the context of biocidal 
active substances and products. Where separa te provisions need to be made with 
respect to the tasks and func tioning of the Agency under this Regulation, it should be 
specified in the provisio ns of this Regulation.  
(58) The costs of the procedures associated with  the operation of this Regulation need to be 
recovered from those seeking to place or pl acing biocidal products on the market and 
from those supporting the entrie s of active substances in A nnex I. In order to promote 
the smooth operation of the in ternal market, the Commissi on should adopt measures to 
harmonise the structure of fee systems es tablished by the Member States and the 
Agency taking into account th e special needs of SMEs.  
(59) It is necessary to provide  for the possibility of an appe al against certai n decisions of 
the Agency. The Board of Appeal set up w ithin the Agency by Regulation (EC) No 
1907/2006 should also guarantee processing of  appeals against decisions adopted by 
the Agency under this Regulation.  
(60) The measures necessary for the implemen tation of this Regulation should be adopted 
in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the 
procedures for the exercise of impl ementing powers conferred on the Commission15. 
(61) In particular, the Commission should be empowered to adopt measures to decide on 
the application to include the active substan ce in Annex I or to renew or review the 
inclusion, to specify the procedures related to the renewal and review of an inclusion 
of an active substance in Annex I, to  extend the provisions on Community 
authorisations to other categ ories of biocidal products, to  specify the criteria and 
procedures related to a cancellation of an authorisation or amendments of the terms 
and conditions of an author isation, including a dispute settlement mechanism, to 
specify the overall applicable  maximum quantities of active substances or biocidal 
products that may be released during ex periments and the minimum data to be 
submitted, to establish a harmonised structure of fees and other rules concerning the payment of fees and charges to the competen t authorities and the Agency, to adapt the 
Annexes to scientific and technical progress,  to carry out the wo rk programme and to 
specify the related rights and obligations  of the competent authorities and the 
participants in the programme and to exte nd the duration of the work programme for a 
determined period. Since those measures ar e of general scope and are designed to 
amend non-essential elements of this Re gulation, inter alia, by supplementing this 
Regulation with new non-essential elements, they must be adopted in accordance with 
the regulatory procedure with scrutiny pr ovided for in Article 5a of Decision 
1999/468/EC. 
(62) When, on imperative grounds of urgenc y, the normal time limits for the regulatory 
procedure with scrutiny cannot be complied with, the Commission should be able to 
apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC 
for the adoption of decisions to amend the in clusion of an active substance in Annex I 
or to remove it from that Annex on basis of Article 13. 
                                                
 
15 OJ L 184, 17.7.1999, p. 23.  
EN 23   EN (63) It is appropriate to pr ovide for a deferred application of this Regulation so as to 
facilitate the smooth transition to the new system applied to the inclusion of active substances in Annex I and author isation of biocidal products.  
(64) Due to the limited number of new submissi ons of applications for inclusion of active 
substances in Annex I, the Agency should ta ke over the co-ordina tion and facilitation 
tasks for new submissions as of the date of  applicability of this Regulation. However, 
in view of the high number of historical do ssiers and in order to allow some time for 
the Agency to prepare for the new role, it should take over the tasks related to dossiers submitted under Directive 98/8/EC as of 1 January 2014. 
(65) In order to respect the legitimate expecta tions of companies with respect to the placing 
on the market and use of low-risk biocidal  products covered Dir ective 98/8/EC, those 
companies should be allowed to place such products on the market if they comply with the rules on the registration of low-risk  biocidal products unde r that Directive. 
However, this Regulation should apply afte r the expiry of th e first registration. 
(66) Taking into consideration that some products were not previously covered by the 
Community legislation in the field of biocid al products, it is appropriate to allow for a 
transitional period for the companies to be prepared to apply th e rules concerning in 
situ generated active substances, treated ar ticles and materials and food contact 
materials. 
(67) In order to ensure an equal treatment  of persons placing on the market biocidal 
products containing one or more  existing active substances, th ey should be required to 
hold a dossier or have a lette r of access to a dossier, or  to each component of the 
dossier, for each of the active substances co ntained in the product. Those persons who 
will not comply with this obligation by 1 January 2014 should no longer be allowed to 
place their products on the market. Appropriate  phase-out periods for disposal, storage 
and use of existing stocks of biocidal pr oducts should be foreseen in such cases. 
(68) This Regulation should take account, as appropriate, of other work programmes 
concerned with the review or  authorisation of substances  and products, or relevant 
international Conventions, 
HAVE ADOPTED THIS REGULATION: 
CHAPTER I 
SCOPE AND DEFINITIONS 
Article 1 
Subject matter  
This Regulation lays down rules for: 
(1) the placing on the market and use of bioc idal products within the Member States or 
the Community; 
(2) the mutual recognition of author isations within the Community;   
EN 24   EN (3) the establishment at Community level of a list of active substances which may be 
used in biocidal products. 
Article 2 
Scope 
1. This Regulation shall apply to biocidal pr oducts as defined in point (a) of Article 
3(1).  
A list of the types of biocidal products  covered by this Regulation and their 
descriptions is set out in Annex V.  
2. This Regulation shall not apply to biocidal  products that are within the scope of the 
following instruments: 
(a) Council Directive 76/76 8/EEC of 27 July 1976 on the approximation of the 
laws of the Member States relating to cosmetic products16; 
(b) Council Directive 82/471/EEC of 30 June 1982 concerning certain products 
used in animal nutrition17; 
(c) Council Directive 88/38 8/EEC of 22 June 1988 on the approximation of the 
laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production
18; 
(d) Regulation (EC) No 1333/2008 of the Eu ropean Parliament and of the Council 
of 16 December 2008 on food additives19; 
(e) Council Directive 90/167/EEC of 26 March 1990 laying down the conditions 
governing the preparation, placing on the market and use of medicated 
feedingstuffs in the Community20; 
(f) Council Directive 90/38 5/EEC of 20 June 1990 on the approximation of the 
laws of the Member States relating to active implantable medical devices21; 
(g) Council Directive 91/414/ EEC of 15 July 1991 concer ning the placing of plant 
protection products on the market22; 
(h) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices23; 
(i) European Parliament and Council Di rective No 95/2/EC of 20 February 1995 
on food additives other than colours and sweeteners24; 
                                                 
16 OJ L 262, 27.9.1976, p. 169.  
17 OJ L 213, 21.7.1982, p. 8.  
18 OJ L 184, 15.7.1988, p. 61.  
19 OJ L 354, 31.12.2008, p. 16. 
20 OJ L 92, 7.4.1990, p. 42. 
21 OJ L 7, 11.1.1994, p. 20 
22 OJ L 230, 19.8.1991, p. 1.  
23 OJ L 169, 12.7.1993, p. 1 
24 OJ L 61, 18.3.1995, p. 1.   
EN 25   EN (j) Council Directive 96/25/EC of 29 April 1996 on the circulation and use of feed 
materials, amending Directives 70/524/EEC, 74/63/EEC, 82/471/EEC and 
93/74/EEC and repealing Directive 77/101/EEC25; 
(k) Directive 98/79/EC of the European Parliament and of the Council of 27 
October 1998 on in vitro diagnostic medical devices26; 
(l) Directive 2001/82/EC of the European  Parliament and of the Council of 6 
November 2001 on the Community code relating to veterinary medicinal 
products27; 
(m) Directive 2001/83/EC of the European  Parliament and of the Council of 6 
November 2001 on the Community code relating to medicinal products for human use
28;  
(n) Regulation (EC) No 1831/2003 of the Eu ropean Parliament and of the Council 
of 22 September 2003 on additives for use in animal nutrition29;  
(o) Regulation (EC) No 852 /2004 of the European Parliament and of the Council 
of 29 April 2004 on the hygiene of foodstuffs30; 
(p) Regulation (EC) No 853 /2004 of the European Parliament and of the Council 
of 29 April 2004 laying down specific hygiene rules for food of animal 
origin31. 
3. Subject to any explicit pr ovision to the contrary, this  Regulation shall be without 
prejudice to the following instruments: 
(a) Council Directive 67/548/EEC 27 June 1967 on the approximation of laws, 
regulations and administrative provi sions relating to the classification, 
packaging and labelling of dangerous substances32; 
(b) Council Directive 79/117/EEC of 21 December 1978 prohibiting the placing on 
the market and use of plant protecti on products contai ning certain active 
substances33; 
(c) Council Directive 89/391/EEC of 12 June 1989 on the introduction of 
measures to encourage improvements in the safety and health of workers at 
work34; 
                                                 
25 OJ L 125, 23.5.1996, p. 35.  
26 OJ L 331, 7.12.1998, p. 1 
27 OJ L 311 , 28.11.2001, p. 1. 
28 OJ  L 311 , 28.11.2001, p. 67. 
29 OJ L 268, 18.10.2003, p. 29.  
30 OJ L 139, 30.4.2004, p. 1. 
31 OJ L 139, 30.4.2004, p. 55.  
32 OJ 196, 16.8.1967, p. 1. 
33 OJ L 33, 8.2.1979, p. 36.  
34 OJ L 183, 29.6.1989, p. 1.   
EN 26   EN (d) Council Directive 98/24/E C of 7 April 1998 on the prot ection of the health and 
safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the mean ing of Article 16(1) of Directive 
89/391/EEC)
35;  
(e) Directive 1999/45/EC of the European  Parliament and of the Council of 31 
May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, 
packaging and labelling of  dangerous preparations
36; 
(f) Directive 2000/54/EC of the European  Parliament and of the Council of 18 
September 2000 on the protection of worker s from risks related to exposure to 
biological agents at work37; 
(g) Regulation (EC) No 1907/2006 of the Eu ropean Parliament and of the Council 
of 18 December 2006 concerning the Regi stration, Evaluation, Authorisation 
and Restriction of Chemicals (REACH),  establishing a European Chemicals 
Agency, amending Directive 1999/45/EC  and repealing Council Regulation 
(EEC) No 793/93 and Commission Regulat ion (EC) No 1488/94 as well as 
Council Directive 76/769/EEC and Co mmission Directives 91/155/EEC, 
93/67/EEC, 93/105/EC and 2000/21/EC38; 
(h) Directive 2006/114/EC of 12 December 2006 of the European Parliament and 
of the Council concerning misleadi ng and comparative advertising39; 
(i) Regulation (EC) No 689 /2008 of the European Parliament and of the Council 
of 17 June 2008 concerning the export and import of dangerous chemicals40; 
(j) [proposal for a Directive of the Eu ropean Parliament and of the Council 
establishing a framework for Community action to achieve the sustainable use 
of pesticides]; 
(k) Regulation (EC) No 1272/2008 of the Eu ropean Parliament and of the Council 
of 16 December 2008 on classification, labe lling and packaging of substances 
and mixtures, amending and repealin g Directives 67/548/EEC and 1999/45/EC, 
and amending Regulation (EC) No 1907/200641. 
4. Article 58 shall not apply to the carriage of  biocidal products by rail, road, inland 
waterway, sea or air. 
5. This Regulation shall not apply to food or feedingstuffs that ar e used for biocidal 
purposes. 
6. This Regulation shall not appl y to processing aids that ar e used for biocidal purposes. 
                                                 
35 OJ L 131, 5.5.1998, p. 11.  
36 OJ L 200, 30.7.1999, p. 1. 
37 OJ L 262, 17.10.2000, p. 21 
38 OJ L 396, 30.12.2006, p. 1.  
39 OJ L 376, 27.12.2006, p. 21.  
40 OJ L 204, 31.7.2008, p. 1.  
41 OJ L 353, 31.12.2008, p. 1.  
EN 27   EN 7. Where a biocidal product is intended by it s manufacturer to be used for the purpose 
of exerting a controll ing effect on any harmful organism present on medical devices 
and for other purposes covered by this Regulation, the relevant essential 
requirements of Directives 90/385/EEC, 93/42/EEC or 98/79/EC shall also be 
fulfilled. 
8. Biocidal products which obtained the final approval under the International 
Convention for the Control and Management of Ships' Ballast Water and Sediments 
shall be considered as authorised under Ch apter VII of this Regulation. Articles 38 
and 57 shall apply accordingly. 
Article 3 
Definitions 
1. For the purposes of this Regulation, th e following definitions shall apply: 
(a) 'biocidal products' means  active substances or mixtures containing one  or more active substances, put up in the 
form in which they are supplied to the user, intended to destroy, deter, render 
harmless, prevent the action of, or otherwis e exert a controlling effect on any harmful 
organism by chemical or biological means. 
All substances, mixtures and devices placed  on the market with the intention to 
generate active substances shall al so be considered biocidal products; 
(b) 'micro-organism' means any microbiological entity, cellular or non-cel lular, capable of replication or of 
transferring genetic material, including lower fungi, viruses, bacteria, yeasts, moulds, 
algae, protozoa and microscopic parasitic helminths;  
(c) 'active substance' means a substance or a micro-organism having an action against harmful organisms;  
(d) 'existing active substance' means a substance which was on the market on 14 May 2000 as an active substance of a 
biocidal product for purposes other than sc ientific or product and process-orientated 
research and development;  
(e) 'new active substance' means a substance which was not on the market on 14 May 2000 as an ac tive substance of a 
biocidal product for purposes other than sc ientific or product and process-orientated 
research and development;  
(f) 'substance of concern' means any substance, other than the active substa nce, which has an inherent capacity to 
cause an adverse effect on humans, animals or the environment and is present or is  
EN 28   EN produced in a biocidal product in sufficient concentration to  present risks of such an 
effect; 
(g) 'harmful organism' means organisms, including pathogenic agents, which have an unwanted presence or a 
detrimental effect on humans, their activities or the products they use or produce, or 
on animals or the environment;  
(h) 'residues' means substances present in or on pl ants or products of plant orig in, edible animal products, 
drinking water or elsewhere in the envir onment and resulting from the use of a 
biocidal product, including their meta bolites, breakdown or reaction products; 
(i) 'placing on the market' means the first supply of a biocidal product fo r distribution or for use on the Community 
market in the course of a commercial activ ity, whether in return for payment or free 
of charge; 
(j) 'use' means all operations carried out with a biocidal product, incl uding storage, handling, mixing 
and application, except any su ch operation carried out w ith view to export of the 
biocidal product out side the Community; 
(k) 'treated material or article' means any substance, mixture, material or articl e which was treated with or incorporates 
one or more biocidal products with the inte ntion to protect the substance, mixture, 
material or article from deterior ation caused by harmful organisms; 
(l) 'national authorisation' means an administrative act by which the competen t authority of a Member State authorises 
the placing on the market and the use of a bioc idal product in its terr itory or in a part 
thereof;  
(m) 'Community authorisation' means an administrative act by which the Commissi on authorises the placing on the market 
and the use of a biocidal product in the te rritory of the Community or in a part 
thereof; 
(n) 'authorisation' means national authorisation or Community authorisation; 
(o) 'unique product formulation' means  
EN 29   EN a biocidal product with no variations as to the percentage of the active substance, the 
percentage composition of the non-active substances, or the perfumes, dyes or 
pigments it contains;  
(p) 'frame formulation' means  a group of biocidal products having similar uses and presenting lim ited variations in 
their composition with regard to a refere nce biocidal product belonging to that group 
which contains the same active substances of the same specifications where such permitted variations do not adversely affect the level of risk or the efficacy of these products; 
(q) 'letter of access' means an original document, signed by the owner or owners of information, which states 
that the information may be used by the competent authorities, the European Chemicals Agency, or the Commission fo r the purpose of evaluating an active 
substance or granting an authorisation; 
(r) 'food and feedingstuff' means food as defined in Article 2 of Regul ation (EC) No 178/2002 of the European 
Parliament and of the Council
42 and feedingstuff as defined in Article 3(4) of that 
Regulation.  
(s) 'food contact materials' means any material and article inte nded to come into contact with food which are covered 
by Regulation (EC) No 1935/2004
43;  
(t) 'processing aid' means any substance which: (i) is not consumed as a f ood or feedingstuff by itself; 
(ii) is intentionally used in the processing of raw materials, foods or feedingstuff or 
their ingredients, to fulfil a certain technological purpose during treatment or 
processing; and 
(iii) may result in the unintentional but technically unavoidable presence in the final 
product of residues of the substance or its derivatives provided they do not present 
any health risk and do not have any te chnological effect on the final product;.  
(u) 'technical equivalence' means similarity as regards the chemical com position and hazard prof ile of a substance 
produced from a new manufact uring source, compared to the substance of the 
reference source with respect to which the initial risk assessment was carried out. 
                                                
 
42 OJ L 31, 1.2.2002, p. 1 
43 OJ L 338, 13.11.2004, p. 4  
EN 30   EN 2. For the purposes of this  Regulation, the definitions laid down in Article 3 of 
Regulation (EC) No 1907/2006 shall apply for the following terms: 
(a) substance; (b) mixture; (c) article; (d) product and process-orientat ed research and development; 
(e) scientific research and development. 
CHAPTER II 
INCLUSION OF AN ACTIVE SUBSTANCE IN ANNEX I 
Article 4 
Conditions for inclusion 
1. An active substance shall be included in Annex I for an initial period not exceeding 
10 years if the biocidal produc ts containing that active subs tance fulfil the conditions 
laid down in point (b) of Article 16(1). 
2. The inclusion in Annex I of an active subs tance shall be restricted to those product 
types in Annex V for which relevant data  have been submitted in accordance with 
Article 6. 
3. An active substance shall, where appropria te, be included in A nnex I together with 
any of the following conditions: 
(a) the minimum degree of purity of the active substance; (b) the nature and maximum c ontent of certain impurities; 
(c) the product type as outlined in Annex V; (d) manner and area of use; (e) designation of categories of users; (f) other particular conditio ns based on the evaluation of the information related to 
that active substance. 
4. Where appropriate, maximum residue limits shall be established with respect to 
active substances included in Annex I in accordance with Regulation (EC) No 396/2005 of the European Parliament and of the Council
44 [and Council Regulation 
(EEC) No 2377/90]. 
                                                 
44 OJ L 70, 16.3.2005, p. 1  
EN 31   EN Article 5 
Exclusion criteria  
1. Notwithstanding Article 4(1), active substan ces referred to in paragraph 2 shall be 
included in Annex I only if at least one of the following conditions is met: 
(a) the exposure of humans to that activ e substance in a biocidal product, under 
normal conditions of use, is negligible, in particular where the product is used 
in closed systems or strictly controlled conditions; 
(b) it is shown that the activ e substance is necessary to control a serious danger to 
public health; 
(c) it is shown that not including the ac tive substance in Annex I would cause 
disproportionate negative impacts when compared with the risk to human 
health or the environment arising from the use of the substance and that there 
are no suitable alternative s ubstances or technologies. 
Point (c) shall not apply to active subs tances for product types 4 and 14 to 19. 
2. The following active substances shall be in cluded in Annex I where at least one of 
the conditions set out in  paragraph 1 is met:  
(a) active substances which have been classified in accordance with Regulation 
(EC) No 1272/2008 as, or which meets th e criteria to be classified as, 
carcinogen category 1A or 1B; 
(b) active substances which have been classified in accordance with Regulation 
(EC) No 1272/2008 as, or which meet the cr iteria to be cla ssified as, mutagen 
category 1A or 1B; 
(c) active substances which have been classified in accordance with Regulation 
(EC) No 1272/2008 as, or which meet the cr iteria to be classified as, toxic for 
reproduction category 1A or 1B; 
(d) active substances identified under Article 57(f) of Regulation (EC) No 
1907/2006 as having endocrine disrupting properties. 
Article 6 
Data requirements for an application  
1. An application to include an active substa nce in Annex I shall contain at least the 
following elements: 
(a) a dossier for the active substance sati sfying the requirements set out in Annex 
II; 
(b) a dossier for at least one representative  biocidal product that  contains the active 
substance satisfying the requirements set out in Annex III.  
The application shall be accompanied by the fees payable under Article 70.  
EN 32   EN 2. Notwithstanding paragraph 1, the applicant need not provi de data required under that 
paragraph if any of the following grounds applies: 
(a) the information is not necessary owi ng to the exposure associated with the 
proposed uses; 
(b) it is not scientifically necessary to supply the information;  (c) it is not technically possibl e to supply the information.  
3. An applicant may propose to adapt the data required under paragraph 1 in accordance 
with Annex IV. The justif ication for the proposed ad aptations to the data 
requirements shall be clearly stated in the a pplication with a reference to the specific 
rules in Annex IV.  
The competent authority shall inform the applicant about the possibility of proposing 
the adaptation of data requi rements, the grounds on which such an adaptation can be 
requested and, where possible, shall provide assistance in preparing such a proposal.  
4. The Commission shall adopt the measures de signed to set the criteria defining what 
constitutes adequate justifi cation to adapt the data re quired under paragraph 1 on the 
ground referred to in paragraph 2(a).  
Those measures designed to amend non-esse ntial elements of this Regulation by 
supplementing it shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 72(4). 
Article 7 
Submission and validation of applications   
1. The applicant shall submit an application to  include an active substance in Annex I, 
or to make subsequent amendments to the conditions of incl usion of an active 
substance, to the European Chemicals Ag ency (hereinafter referred to as 'the 
Agency') and inform it of the name of th e competent authority of the Member State 
that he chooses to evaluate his applica tion. That competent authority (hereinafter 
referred to as 'the evaluating competent authority') shall be responsible for the 
evaluation of the application.  
2. The Agency shall, within one month from  the receipt of the application, notify the 
evaluating competent authority that the a pplication is available in the Agency 
database. 
3. Within two months after th e receipt of an application, the Agency shall validate the 
application if it complies with the following requirements: 
(a) dossiers referred to in points (a) and (b) of Article 6(1) have been submitted; (b) it is accompanied by the fees payable under Article 70. The validation shall not include an assessmen t of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted.  
EN 33   EN 4. If the Agency considers that the applic ation is incomplete, it shall inform the 
applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.  
The Agency shall, within two months after the receipt of the additional information, 
determine whether the additional informati on submitted is sufficient to validate the 
application. 
The Agency shall reject the application if the applicant fails to submit the requested 
information within the deadline and shall info rm the applicant thereof. In such cases 
a part of the fee paid to the Agency in accordance with Article 70 shall be 
reimbursed.  
5. An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the third subparagraph of paragraph 4.  
6. If the Agency, on the basis of the valida tion made pursuant to paragraph 3, considers 
that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof. 
Article 8 
Evaluation of applications 
1. The evaluating competent authority shall,  within 12 months af ter the validation, 
evaluate the dossiers in accordance with Article 4 including, where relevant, any 
proposal to adapt data requirements subm itted in accordance with Article 6(3).  
The evaluating competent authority shall prov ide the applicant with an opportunity to 
provide written or oral co mments on the conclusions of the evaluation within two 
months. The evaluating competent author ity shall take due account of these 
comments when finalis ing its evaluation. 
The evaluating competent authority shall se nd the conclusions of the evaluation to 
the Agency.  
2. If, when the dossiers are ev aluated, it appears that additi onal information is necessary 
to carry out the evaluation, the evaluating co mpetent authority shall ask the applicant 
to submit such information within a specified  time limit, and shal l inform the Agency 
thereof.  
The 12-month period referred to in paragraph 1 shall be suspended from the date of 
issue of the request until the date  the information is received.  
3. If the evaluating competent authority consider s that there are concerns with regard to 
the cumulative effects from the use of bi ocidal products contai ning the same active 
substance, it shall document its concerns in  accordance with the requirements of the 
relevant parts of Section II.3 of A nnex XV to Regulation (EC) No 1907/2006 and 
include this as part  of its conclusions.  
EN 34   EN 4. Within nine months after the receipt of th e conclusions of the evaluation, the Agency 
shall prepare and submit to the Commission an opinion on the inclusion of the active substance in Annex I.  
5. On receipt of the opinion of the Agenc y, the Commission shall adopt a decision on 
the application to include the active substan ce in Annex I. That decision, designed to 
amend non-essential elements of this Re gulation by supplementing it, shall be 
adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 72(4). 
6. Notwithstanding Article 7(1), the evaluation of the application ma y be carried out by 
the competent authority ot her than the one which ha s received the copy of the 
application.  
The competent authority that has been notif ied of the application for the evaluation 
may submit a duly substantiated request to  appoint another evaluating competent 
authority to the Commission within one m onth after the receipt of the notification 
referred to in Article 7(2). The Commissi on shall take the decision in accordance 
with the procedure referred to in Article  72(2). The 12-month period referred to in 
paragraph 1 shall commence on the da te when this decision is taken. 
Article 9 
Active substances which are candidates for substitution 
1. An active substance fulfilling at least one of  the following criteria shall be considered 
a candidate for substitution in accordance w ith the procedure referred to in paragraph 
2: 
(a) its acceptable daily intake, acute re ference dose or acceptable operator 
exposure level is significantly lower than  those of the majo rity of the active 
substances included in Annex I for the same product type; 
(b) it meets two of the criteria to be cons idered as a persistent, bio-accumulative 
and toxic substance as set out in Annex XIII of Regulation (EC) No 
1907/2006; 
(c) there are reasons for concern linked to the nature of the cr itical effects, in 
particular developmental neurotoxic or immunotoxic effects, which, in 
combination with the use patterns, amount to use that could still cause concern, 
even with very restrictive risk management measures; 
(d) it contains a significant pr oportion of non-active isomers; 
(e) it is classified or meets the criteria  to be classified, in accordance with 
Regulation (EC) No 1272/2008, as carci nogen category 1A or 1B, mutagen 
category 1A or 1B or toxic for reproduction category 1A or 1B; 
(f) it is considered to have endocrine di srupting properties that may cause adverse 
effect on humans on the basis of the assessment of Community or 
internationally agreed test guide lines or other available data.  
EN 35   EN 2. When preparing an opinion on the inclusion or renewal of the inclusion of an active 
substance in Annex I, the Ag ency shall examine whether the active substance fulfils 
any of the criteria listed in  paragraph 1 and address th e matter in its opinion.  
3. Prior to submitting the opinion on the inclusion or renewal of the inclusion of an 
active substance in Annex I to the Commission, the Agency shall make publicly available information on potential candida tes for substitution with a reasonable 
period during which relevant informati on, including information on available 
substitutes, may be submitted by interested third parties. The Agency shall take due 
account of the information receiv ed when finalising its opinion. 
4. By way of derogation from Article 10(3), the inclusion of an active substance in 
Annex I that is considered as a candidate for substitution shall be renewed for a 
period not exceeding ten years. 
5. Active substances that are considered as candidates for substitution in accordance 
with paragraph 1 shall be identified as such in Annex I. 
CHAPTER III 
RENEWAL AND REVIEW OF AN ACTIVE SUBSTANCE 
INCLUSION 
Article 10 
Conditions for renewal  
1. The Commission shall renew the inclusion of  an active substance in Annex I if the 
active substance still complies with the re quirements referred to in Article 4.  
2. Based on new elements examined or adaptati ons to technical progress, the renewal of 
the inclusion may be accompanied, as appr opriate, by conditions and restrictions.  
3. Unless otherwise specified in the decisi on to renew the inclusion of an active 
substance in Annex I, th e renewal shall be for an  unlimited period of time. 
Article 11 
Submission and validation of applications  
1. The applicant shall submit the application for renewal of the inclusion of an active 
substance in Annex I to the Agency at le ast 18 months before the expiry of the 
inclusion in Annex I for a given product-type  
The application shall be accompanied by the fees payable under Article 70. 
When applying for renewal, the applicant shall submit a list of all data relating to the 
active substance that have been generated since the inclusion of the active substance 
in Annex I and a justification as to whethe r the conclusions of the initial assessment 
of the active substance are still valid. The evaluating competent authority may 
require the applicant to submit the data re ferred to in this list at any time. 
2. The Agency shall, within one month afte r the receipt of the application, notify the 
evaluating competent authority that carri ed out the initial evaluation of the  
EN 36   EN application for inclusion in Annex I that th e application is available in the Agency 
database. 
3. Within two months after th e receipt of an application, the Agency shall validate the 
application if it complies with the following requirements: 
(a) information referred to paragraph 1 has been submitted; (b) it is accompanied by the fees payable under Article 70. The validation shall not include an assessmen t of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 
4. If the Agency considers that the applic ation is incomplete, it shall inform the 
applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.  
The Agency shall, within two months after the receipt of the additional information, 
determine whether the additional informati on submitted is sufficient to validate the 
application. 
The Agency shall reject the application if the applicant fails to submit the requested 
information within the deadline and shall info rm the applicant thereof. In such cases 
a part of the fee paid to the Agency in accordance with Article 70 shall be 
reimbursed. 
5. An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the third subparagraph of paragraph 4.  
6. If the Agency, on basis of the validation ma de pursuant to paragraph 3, considers that 
the application is complete , it shall without delay info rm the applicant and the 
evaluating competent authority thereof. 
Article 12 
Evaluation of applications for renewal 
1. On the basis of the available information and a need to review the conclusions of the 
initial evaluation of the application fo r inclusion in Annex I, the evaluating 
competent authority that carried out the in itial evaluation shall, within one month 
after the validation referred to in Article  11, decide whether a full evaluation of the 
application for renewal is necessary.  
If the evaluating competent authority decide s that a full evaluation of the application 
is necessary, the evaluation sh all be carried out in accordan ce with paragraphs 1 to 4 
of Article 8. The decision on the applicatio n shall be adopted in accordance with 
paragraphs 5, 6 and 7 of this Article.  
2. If the evaluating competent authority decide s that a full evaluation of the application 
is not necessary, it shall, within six m onths, prepare and submit to the Agency a 
recommendation on the renewal of the inclusi on of the active substance in Annex I.   
EN 37   EN Prior to submitting the recommendation to  the Agency, the evaluating competent 
authority shall provide the applicant with an  opportunity to provi de written or oral 
comments on the recommendation within one  month. The evaluating competent 
authority shall take due account of these comments when finalising its recommendation. 
3. On the receipt of the recommendation fr om the evaluating competent authority, the 
Agency shall make it available to the Comm ission, the competent authorities of other 
Member States and the applicant and allo w a period of three months during which 
they may submit written comments to it. 
4. The Commission may ask the Agency for an opinion on scien tific or technical 
matters raised by a competent authority objecting to the recommendation referred to in paragraph 2. The Agency shall issue an opinion within six months from the date on which the matter was referred to it. 
5. At the end of the period referred to in pa ragraph 3 or on receipt of the opinion of the 
Agency, the Commission shall adopt a decision concerning a renewal of the 
inclusion of the active subs tance in Annex I. That decision, designed to amend non-
essential elements of this Regulation by supplementing it, shall be adopted in 
accordance with the regulatory procedure with scrutiny referred to in Article 72(4). 
6. Where, for reasons beyond the control of the applicant, the inclusion of the active 
substance in Annex I is likel y to expire before  a decision has been taken on its 
renewal, the Commission shall, in accordan ce with the procedure referred to in 
Article 72(2), adopt a decision postponing the expiry date of incl usion for a period 
sufficient to enable it to examine the application.  
7. Where the Commission decides not to renew the inclusion of an active substance in 
Annex I, it may grant a period of grace for the disposal, storage, placing on the market and use of existing stocks of bi ocidal products cont aining that active 
substance.  
The period of grace shall not exceed six m onths for the placing on the market and an 
additional maximum of twelve months for th e disposal, storage, and use of existing 
stocks of the biocidal products containing that active substance. 
Article 13 
Review of inclusion of an active substance in Annex I 
1. The Commission may review the inclusion of  an active substance in Annex I at any 
time where there are serious indications that the requirements referred to in Article 4 are no longer complied with. Where those indications are confirmed, the Commission shall adopt a deci sion amending the inclusion of  an active substance in 
Annex I or removing it from that Annex.  
That decision, designed to amend non-essen tial elements of this Regulation, shall be 
adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 72(4). On imperative grounds of ur gency, the Commission may have recourse 
to the urgency procedure referred to in Article 72(5).  
EN 38   EN 2. The Commission may consult the Agency on any questions of a scientific or 
technical nature related to the review of in clusion of an active substance in Annex I. 
The Agency shall, within nine months from the request, prep are an opinion and 
submit it to the Commission. 
3. Where the Commission removes the entry of  an active substance from Annex I, it 
may grant a period of grace for the disposal , storage, placing on the market and use 
of existing stocks of biocidal products  containing that active substance.  
The period of grace shall not exceed six m onths for the placing on the market and an 
additional maximum of twelve months for th e disposal, storage, and use of existing 
stocks of the biocidal products containing that active substance. 
Article 14 
Implementing measures 
The Commission may adopt detailed measures fo r the implementation of Articles 10 to 13 of 
this Regulation specifying the procedures related to the renewal and review of an inclusion of 
an active substance in Annex I.  
Those measures, designed to amend non-esse ntial elements of this Regulation by 
supplementing it, shall be adopted in accordance  with the regulatory procedure with scrutiny 
referred to in Article 72(4). 
CHAPTER IV 
GENERAL PRINCIPLES OF  AUTHORISATION OF 
BIOCIDAL PRODUCTS 
Article 15 
Placing on the market and use of biocidal products  
1. No biocidal product may be placed on the ma rket or used unless an authorisation has 
been issued for that biocidal produc t in accordance with this Regulation. 
2. Application for authorisati on shall be made by, or on beha lf of, the person who shall 
be responsible for the placing on the market  of a biocidal product in a particular 
Member State or in the Community. 
Application for national author isation in a Member State shall be submitted to the 
competent authority of that Member State (h ereinafter referred to as 'the receiving 
competent authority'). 
Application for Community authorisati on shall be submitted to the Agency.  
A holder of an authorisation shall have a permanent office within the Community.  
3. An authorisation may be granted for a unique product formulation or for a frame 
formulation.  
4. An authorisation shall be granted for a maximum period of 10 years.  
EN 39   EN 5. Biocidal products shall be used proper ly. Proper use shall include compliance with 
the conditions for granting an authorisatio n established by Article  16 and labelling 
requirements laid down in Article 58.  
Proper use shall also involv e the rational application of  a combination of physical, 
biological, chemical or other measures as appropriate, whereby the use of biocidal 
products is limited to the minimum necessary.  
Article 16 
Conditions for granting an authorisation 
1. A biocidal product shall be authorised  only if the following conditions are met: 
(a) the active substances included therein are listed in Annex I and any conditions 
included in that Annex together with those active substances are complied with; 
(b) it is established according to the co mmon principles for the evaluation of 
dossiers for biocidal products laid down in Annex VI, that the biocidal product, 
when used as authorised and having regard to the factors referred to in paragraph 2, complies with the following criteria: 
(i) it is sufficiently effective; 
(ii) it has no unacceptable effects on the target organisms, in particular 
unacceptable resistance or cross-resist ance or unnecessary suffering and 
pain for vertebrates; 
(iii) it has no unacceptable eff ects itself or as a result of its residues, directly 
or indirectly, on huma n or animal health; 
(iv) it has no unacceptable effects itself, or as a result of its residues, on the 
environment having particular regard  to the following considerations: 
- its fate and distributi on in the environment;  
- contamination of surface waters (i ncluding estuarial and seawater), 
groundwater and drinking water, air and soil; 
- its impact on non-target organisms; - its impact on biodiversity and the ecosystem; 
(c) the nature, the quantity and the technical  equivalence of active substances in 
the biocidal product and, where appr opriate, any toxicologically or 
ecotoxicologically signif icant impurities and non-act ive substances, and its 
residues of toxicological or environmenta l significance, which result from uses 
to be authorised, can be determined acco rding to the relevant  requirements in 
Annexes II and III;  
EN 40   EN (d) its physical and chemical propertie s have been determined and deemed 
acceptable for purposes of the appropriate use, storage and transport of the product. 
2. The evaluation of the compliance of the bi ocidal product with th e criteria set out in 
point (b) of paragraph 1 shall take  into account the following factors: 
(a) all normal conditions under whic h the biocidal product may be used; 
(b) how any material or article treated with it or containing it may be used; 
(c) the consequences of its use and disposal. 
3. An authorisation to place a low-risk biocidal product on the market shall be subject 
to compliance with the requirements of points (b), (c) and (d) of paragraph 1. 
4. A biocidal product shall only be authorised  for uses for which relevant information 
has been submitted in accordance with Article 18. 
5. A biocidal product shall not be  authorised for placing on th e market to, or use by, the 
general public if it fulfils any of the following criteria for classification: 
(a) toxic, very toxic or a category 1 or 2 carcinogen, or a category 1 or 2 mutagen 
or toxic for reproduction category 1 or 2 according to Directive 1999/45/EC; 
(b) toxic, very toxic or a category 1A or  1B carcinogen, or a category 1A or 1B 
mutagen or toxic for reproduction categor y 1A or 1B according to Regulation 
(EC) No 1272/2008.  
6. In the case of a frame formulation, a reduction in the percentage of the active 
substance in the reference bi ocidal product may be allowe d, and/or an alteration in 
percentage composition of one or mo re non-active substances, and/or the 
replacement of one or more non-active subs tances by others presenting the same or 
lower risk. 
Article 17 
Criteria for low-risk biocidal products 
1. A biocidal product shall be considered a low-risk biocidal product if both the 
following conditions are fulfilled: 
(a) for any given environmental compar tment, the ratio of the predicted 
environmental concentration (PEC) to  predicted no-effect concentration 
(PNEC) may be derived and does not exceed 0.1;  
(b) for any effect to human health, th e margin of exposure (the ratio of no 
observed adverse effect le vel (NOAEL) and exposure concentration) is higher 
than 1,000. 
However, a biocidal product shall not be c onsidered a low-risk biocidal product if at 
least one of the following conditions is present:  
EN 41   EN (a) it contains one or more active substances which fulfil the criteria for being 
persistent, bio-accumulative and toxic (P BT) or very persistent and very bio-
accumulative (vPvB) in accordance with  Annex XIII of Regulation (EC) No 
1907/2006; 
(b) it contains one or more active substan ces qualified as endocrine disrupters;  
(c) it contains one or more active substa nces which have been classified in 
accordance with Regulation (EC) No 1272/ 2008 as or which meets the criteria 
to be classified as one of the following: 
(i) carcinogenic; (ii) mutagenic; (iii) neurotoxic; (iv) immunotoxic; (v) toxic to reproduction; (vi) sensitising. 
2. Notwithstanding paragraph 1, a biocidal pr oduct shall be considered a low-risk 
biocidal product if the active substances in the biocidal pr oduct are contained in such 
way that only a negligible exposure can take place under normal conditions of use 
and the product is handled under strictly controlled conditions during all other stages 
of its lifecycle. 
3. For a low-risk biocidal pr oduct it shall be demonstrated  that the pot ential for the 
development of resistance in target organisms due to the use of the biocidal product 
is low.  
4. In addition to the active substances refe rred to in Article 15(2 ) of Regulation (EC) 
No 1907/2006, active substances manufactured or importe d for use in low-risk 
biocidal products that are authorised for placing on the market in accordance with Article 15 shall be regarded as being regist ered and the registration as completed for 
manufacture or import for use in a low -risk biocidal product and therefore as 
fulfilling the requirements of Chapters 1 and 5 of Title II of that Regulation. 
Article 18 
Data requirements for an application for authorisation 
1. The applicant for an authorisation shal l submit the following documents together 
with the application: 
(a) a dossier or letter of access for the biocidal product satisfying the requirements 
set out in Annex III;  
(b) a proposal for a summary of the biocid al product characteri stics that includes 
the information referred to in points (a ), (b) and (e) to (m) of Article 20(2);  
EN 42   EN (c) for other than low-risk biocidal products, a dossier or a letter of access to a 
dossier satisfying the requirements se t out in Annex II for each active 
substance in the biocidal product; 
(d) for low-risk biocidal products, any relevant information in support of the 
conclusion that the biocidal product is to be considered a low-risk biocidal 
product. 
2. The application for author isation shall be accompanie d by the fees payable under 
Article 70. 
3. The receiving competent authority may require that applications for a national 
authorisation be submitted in one or more of the official languages of the Member 
State where that competent authority is situated. 
4. If the application concerns a biocidal produc t that is intended by its manufacturer to 
be used also for the purposes referred to in Article 2(7), it shall be accompanied by a 
declaration of conformity regarding the compliance with the relevant essential 
requirements of Directives 90/ 385/EEC, 93/42/EEC or 98/79/EC. 
5. The Commission, in accordance with the pro cedure referred to in Article 72(2), shall 
draw up technical notes for guidance to fac ilitate the implementation of point (d) of 
paragraph 1. 
The technical notes shall be published in the ‘C’ series of the Official Journal of the 
European Union . 
Article 19 
Waiving of data requirements 
1. Notwithstanding Article 18, th e applicant need not provide  data required under that 
Article if any of the following grounds applies: 
(a) the information is not necessary owi ng to the exposure associated with the 
proposed uses; 
(b) it is not scientifically necessary to supply the information;  (c) it is not technically possibl e to supply the information.  
2. The applicant may propose to adapt the data required under Article 18 in accordance 
with Annex IV. The justif ication for the proposed ad aptations to the data 
requirements shall be clearly stated in the application with reference to the specific 
rules in Annex IV. 
The competent authority shall inform the applicant about the possibility of proposing 
the adaptation of data requi rements, the grounds on which such an adaptation can be 
requested and, where possible,  shall provide assistance in  preparing such a proposal. 
3. The Commission shall adopt the measures de signed to set the criteria defining what 
constitutes adequate justification to ad apt the data required under Article 18 on the 
ground referred to in paragraph 1(a).   
EN 43   EN Those measures designed to amend non-esse ntial elements of this Regulation by 
supplementing it shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 72(4). 
Article 20 
Content of authorisation  
1. An authorisation shall stipulate the term s and the conditions relating to the placing on 
the market and use of the biocidal product. 
2. An authorisation shall include the summar y of the biocidal pr oduct characteristics 
listing the following information: 
(a) trade name of the biocidal product; (b) name and address of the authorisation holder; 
(c) date of the authorisati on and its date of expiry; 
(d) authorisation number; (e) qualitative and quantitative composition in terms of the active substances and 
non-active substances, knowle dge of which is essential for proper use of the 
biocidal product; 
(f) manufacturers of the biocidal product (names and addresses including location 
of manufacturing sites); 
(g) manufacturers of the active substances  (names and addresses including location 
of manufacturing sites); 
(h) physical state and nature  of the biocidal product; 
(i) hazard and precautionary statements; (j) the product-type in accordance with Annex V and the target harmful 
organisms; 
(k) application doses and instructions for use; 
(l) categories of users; (m) particulars of likely direct or indirect  adverse effects and fi rst aid instructions; 
(n) instructions for safe disposal  of the product and its packaging; 
(o) in the case of a biocidal product that is intended by its manuf acturer to be used 
also for the purposes referred to in Artic le 2(7), any specific use conditions and 
a statement that the biocidal product is in  conformity with th e relevant essential 
requirements of Directives 90/ 385/EEC, 93/42/EEC or 98/79/EC.  
3. In addition to paragraph 2, in the case of a frame formulation, the authorisation shall 
indicate, as appropriate, th e following information:  
EN 44   EN (a) the reference biocidal product within  the group of products comprising the 
frame formulation that has the highest allowed concentration of the active substances;  
(b) the permitted alteration of the compos ition of this reference biocidal product 
expressed in percentage of the non-active substances contained in the biocidal 
products which are considered to belong to that frame formulation;  
(c) the non-active substances that may be substituted in the au thorised biocidal 
products belonging to that frame formulation. 
Article 21 
Comparative assessment of biocidal products   
1. The receiving competent authority or, in th e case of evaluation of an application for a 
Community authorisation, the evaluating competent authority shall perform a 
comparative assessment as part of the evaluation of an application for an 
authorisation or a renewal of an authoris ation of a biocidal product containing an 
active substance that is a candidate for s ubstitution in accordance with Article 9(1).  
2. The results of the comparat ive assessment shall be forw arded, without delay, to the 
competent authorities of other Member St ates and the Agency and, in the case of 
evaluation of an application for a Commun ity authorisation, also to the Commission. 
3. The receiving competent authority or, in the case of a decision on an application for a 
Community authorisation, the Commission sh all prohibit or restrict the placing on 
the market or use of a biocidal product containing an active substance that is a 
candidate for substitution where the co mparative assessment weighing up the risks 
and benefits in accordance with Annex VI de monstrates that all the following criteria 
are met: 
(a) for the uses specified in the applicati on, another authorised biocidal product or 
a non-chemical control or prevention me thod already exists which presents 
significantly lower risk for human or animal health or the environment;  
(b) the biocidal product or non-chemical control or prevention method referred to 
in point (a) does not presen t significant economic or pr actical disadvantages;  
(c) the chemical diversity of the active substances is adequate to minimise the 
occurrence of resistance in th e target harmful organism.  
4. By way of derogation from paragraph 1, a biocidal product containing an active 
substance that is a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary  to acquire experien ce first through using 
that product in practice. 
5. Where the comparative assessment involve s a question which, by reason of its scale 
or consequences, would be better addresse d at the Community level, in particular 
where it is relevant to two or more comp etent authorities, the receiving competent 
authority may refer the question to the Co mmission for a decisi on. The Commission 
shall adopt the decision in accordance with Article 72(3).  
EN 45   EN The Commission shall adopt implementing rule s specifying the procedures related to 
comparative assessments involving questions  of Community interest. Those rules, 
designed to amend non-essential elements of this Regulation by supplementing it, 
shall be adopted in accordance with the re gulatory procedure with  scrutiny referred 
to in Article 72(4). 
6. Notwithstanding Article 15(4), an authorisation for a bioc idal product containing an 
active substance that is a candidate for substitution shall be granted for a period not exceeding five years. 
7. Where it is decided not to authorise or to restrict the use of a biocidal product 
pursuant to paragraph 3, that cancellation or amendment of the authorisation shall 
take effect five years after the decision or  at the end of the in clusion period of the 
candidate for substitution, whichever is the earlier. 
CHAPTER V 
NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS 
Article 22 
Submission and validation of application 
1. Within one month after the receipt of an  application for a national authorisation 
referred to in Article 15, the receiving competent au thority shall validate the 
application if it complies with the following requirements:  
(a) the information referred to in Article 18 has been submitted; (b) it is accompanied by the fees payable under Article 70. The validation shall not include an assessmen t of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 
2. If the receiving competent authority considers that the application is incomplete, it 
shall inform the applicant as to what a dditional information is required for the 
validation of the application and shall set a reasonable time limit for the submission of that information.  
The receiving competent authority shall, w ithin one month from the receipt of the 
additional information, determine whether the additional information submitted is 
sufficient to validate the application. 
The receiving competent authority shall reject  the application if the applicant fails to 
submit the requested information within the deadline and inform the applicant 
thereof.  
3. If the receiving competent authority, on ba sis of the validation made pursuant to 
paragraph 1, considers that the application is  complete, it shall without delay inform 
the applicant thereof.  
EN 46   EN Article 23 
Evaluation of application  
1. The receiving competent authority shall, within twelve months after the validation 
referred to in Article 22, decide on the application in accordance with Article 16. 
2. If an application relating  to the same biocidal produc t is being examined by the 
competent authority of another Member St ate or if the competent authority of 
another Member State has already author ised the same biocidal product, the 
receiving competent authority shall decline to assess the application and inform the 
applicant thereof.  
However, the applicant may request that his application be assessed in accordance 
with Article 25 or 28. 
3. If it appears that additional information is necessary in order to carry out a full 
evaluation of the applicati on, the receiving competent authority shall request the 
applicant to submit such information. The twelve-month period referred to in 
paragraph 1 shall be suspended from the date of issue of the request until the date the 
information is received. 
4. The receiving competent authority shall draft a report summarising the conclusions 
of its assessment and the reasons for author ising a biocidal product or for refusing to 
grant an authorisation. The receiving competent authority shall send the draft assessment report to the applicant who sha ll be provided with the opportunity to 
submit oral or written comments within  one month. The receiving competent 
authority shall take due account of these comments when finalising its assessment. 
The receiving competent authority shall a pprove the summary of the biocidal product 
characteristics referred to in Article 20(2). It shall forward the a pplicant a copy of the 
final assessment report. 
5. As soon as the receiving competent authority has taken a decision on an application, 
it shall enter the following information in the Community Register of Biocidal 
Products : 
(a) the summary of biocidal product characteristics; (b) the report summarising the conclusions of the assessment of the biocidal 
product and the reasons for authorising the biocidal product or refusing to authorise it; 
(c) the administrative decisions taken by the receiving competent authority 
concerning the application. 
Article 24 
Renewal of a national authorisation 
1. The authorisation holder or his representati ve shall submit an application for renewal 
of a national authorisation to the receiving  competent authority at least 18 months 
before the expiry date of the authorisation.   
EN 47   EN The application shall be accompanied by the fees payable under Article 70. 
2. The receiving competent authority shall renew the national authorisation, provided 
that the conditions set out in Article 16 are still satisfied.  
3. When applying for renewal, the applicant sha ll submit a list of all data related to the 
biocidal product that have been generate d since the previous authorisation and a 
justification as to whether the conclusions of the initial assessment of the biocidal 
product are still valid.  
The receiving competent authority may require the applicant to submit the data 
referred to in the list at any time.  
4. Within one month after the receipt of an  application for a renewal of a national 
authorisation, the receiving competent aut hority shall validate the application if it 
complies with the following requirements:  
(a) the information referred to in paragraph 3 has been submitted; (b) it is accompanied by the fees payable under Article 70. The validation shall not include an assessmen t of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 
5. If the receiving competent authority consid ers that the application is incomplete, it 
shall inform the applicant as to what a dditional information is required for the 
validation of the application and shall set a reasonable time limit for the submission of that information.  
The receiving competent authority shall, w ithin one month from the receipt of the 
additional information, determine whether the additional information submitted is 
sufficient to validate the application. 
The receiving competent authority shall reject  the application if the applicant fails to 
submit the requested information within the deadline and inform the applicant 
thereof.  
If the receiving competent authority, on ba sis of the validation made pursuant to 
paragraph 4, considers that the application is  complete, it shall without delay inform 
the applicant thereof. 
6. The decision on the application for renewa l of the national authorisation shall be 
taken within six months  after the validation. 
7. If, when the application for renewal is evaluated, it appears that additional 
information is necessary in order to carry out a full evaluation of the application, the 
receiving competent authority shall ask that  the applicant submits such information. 
The six-month period referred to in paragra ph 6 shall be suspended from the date of 
the request until the date the information is received. 
8. Where, for reasons beyond the control of the holder of the nati onal authorisation, no 
decision is taken on the renewal of the nati onal authorisation before its expiry, the  
EN 48   EN receiving competent authority shall grant th e renewal of the national authorisation for 
the period necessary to complete the evaluation. 
9. As soon as the competent authority has ta ken a decision concerning the renewal of a 
national authorisation, it shall enter the inform ation referred to in Article 23(5) in the 
Community Register of Biocidal Products . 
CHAPTER VI 
MUTUAL RECOGNITION PROCEDURES 
Article 25 
Mutual recognition of national  authorisations in sequence  
1. The holder of a national aut horisation for a biocidal pr oduct granted by a competent 
authority in accordance with Article 15 (her einafter referred to as 'the reference 
competent authority') may apply for a nati onal authorisation of the biocidal product 
in another Member State under the mutu al recognition procedure in sequence. 
2. The application for mutual recognition shall be accompanied by: 
(a) a reference to the national authoris ation granted by the reference competent 
authority; 
(b) an electronic summary of the dossier satisfying the requi rements set out in 
Annex III; 
(c) a reference to the report of the refe rence competent authority summarising the 
conclusions of its assessment and the reasons for authorising the biocidal product. 
The application shall be accompanied by the fees payable under Article 70. 
3. The receiving competent authority may require a translation of the national 
authorisation and application into one or several of the official languages of the 
Member State where that competent authority is situated. 
4. The receiving competent authority shall deci de on the application within four months 
of the receipt of the application.  
5. The receiving competent authority shall authorise the biocidal product concerned 
under the same conditions as the reference competent authority. 
6. As soon as the competent authorities have  taken a decision on an application for 
mutual recognition of a national authorisatio n under this Article, they shall enter the 
information referred to in points (a) and (c) of Article 23(5) in the Community 
Register of Biocidal Products .  
EN 49   EN Article 26 
Application for mutual recognit ion by pest control bodies 
1. Where no application for a national authorisation has been submitted in a Member 
State for a biocidal product that is alre ady authorised in a nother Member State, 
official or scientific bodies involved in  pest control activities or professional 
organisations may apply, with the consent of the authorisation holder in another 
Member State, for a national authorisation for the same biocidal product, the same 
use and under the same conditions for use in that Member State under the mutual recognition procedure provide d for in Article 25.  
The applicant shall demonstrate that the use of such a biocidal pr oduct is of general 
interest for that Member State.  
The application shall be accompanied by the fees payable under Article 70. 
2. By way of derogation from paragraph 1, wher e the authorisation ho lder does not give 
his consent, the applicant may indicate that in the application and the competent authority of the Member State concerned may accept the application on grounds of 
public interest.  
3. If the competent authority of the concerne d Member State considers that the biocidal 
product fulfils the conditions referred to in Article 16 and the conditions under this 
Article are complied with, the competent authority shall authorise the placing of the biocidal product on the market.  
4. The official or scientific  bodies involved in pest cont rol activities or  professional 
organisations shall have the rights and ob ligations of the authorisation holder. 
Article 27  
Objections regarding the condition s for a national authorisation 
1. When the competent authority, within four months of the receipt  of the application 
for mutual recognition, consider s that a biocidal product, which has been authorised 
in another Member State, does not satisf y the requirements of Article 16, it shall 
without delay notify the Commission, the comp etent authorities of the other Member 
States and the applicant thereof and sh all provide them with an explanatory 
document identifying the biocidal product and its specifications and setting out the 
grounds on which it proposes to refuse to recognise or to restrict the national 
authorisation. 
The Commission shall adopt a decision on whether the grounds set out by the 
competent authority justify refusal to r ecognise, or restriction of, the national 
authorisation in accordance with the pro cedure referred to in Article 72(3).  
2. If the Commission decision confirms the gr ounds presented for refu sing or restricting 
the subsequent authorisation, the competent authority that had previously authorised 
the biocidal product shall wit hout delay review its nationa l authorisation to comply 
with that decision.   
EN 50   EN If the Commission decision confirms the in itial national authoris ation, the competent 
authority that proposed to refuse to recogni se a national authorisa tion, or to recognise 
the national authorisation subj ect to certain conditions, sh all without delay authorise 
the biocidal product concer ned in accordance with th e initial authorisation. 
Article 28 
Mutual recognition of national  authorisations in parallel 
1. If the applicant seeks to r eceive national authorisations for a biocidal product in more 
than one Member State in pa rallel, he shall submit to a reference competent authority 
of his choice an application containing: 
(a) information referred to in Article 18;  (b) a list of all other Member States where a national auth orisation is sought 
(hereinafter referred to as the 'o ther concerned Member States').  
The application shall be accompanied by the fees payable under Article 70. 
The reference competent authority shall be  responsible for th e evaluation of the 
application. 
2. The applicant shall submit to the compet ent authorities of the other concerned 
Member States an application for mutual r ecognition of the author isation for which it 
has applied to the reference competent au thority. This application shall contain: 
(a) an electronic summary of the do ssier as required in Annex III; 
(b) the names of the reference competent authority and of the other concerned 
Member States.  
3. The reference competent authority shall, within one month after the receipt of an 
application referred to in paragraph 1, valid ate the application if it complies with the 
following requirements: 
(a) the information referred to in paragraph 1 has been submitted; (b) it is accompanied by the fees payable under Article 70. The validation shall not include an assessmen t of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted.  
4. If the reference competent authority considers that the application is incomplete, it 
shall inform the applicant as to what a dditional information is required for the 
validation of the application and shall set a reasonable time limit for the submission of that information. The reference competen t authority shall also inform the other 
concerned Member States. 
The reference competent authority shall, w ithin one month after the receipt of the 
additional information, determine whether the additional information submitted is 
sufficient to validate the application.  
EN 51   EN The reference competent authority shall reject the application if the applicant fails to 
submit the requested information within the deadline and shall inform the applicant and the other concerned Me mber States thereof.  
5. If the reference competent authority, on th e basis of the valida tion made pursuant to 
paragraph 3, considers that the application is  complete, it shall without delay inform 
the applicant and the other concerned Member States. 
6. The reference competent authority shall evaluate the information referred to in 
paragraph 1 and prepare a report summarising the conclusions of its assessment and a 
draft of the summary of the biocidal produc t characteristics with in 12 months from 
the receipt of a valid app lication and shall communicate the report and the draft 
summary to the competent authorities of other concerned Member States and the 
applicant. The reference competent authority shall send the draft assessment report to the applicant who shall be provided with th e opportunity to submit oral or written 
comments within one month. The referen ce competent authority shall take due 
account of these comments when finalising its assessment. 
7. Within four months after receipt of th e documents referred to in paragraph 6, the 
competent authorities of other concer ned Member States shall approve the 
assessment report and the summary of the product characteristics, and shall inform 
the reference competent authority accordingly.  
8. The reference competent authority and the competent authorities of the other 
concerned Member States shall authorise the biocidal product on the basis of the 
approved assessment report and the summary of the biocidal product characteristics 
within one month after th e end of the period refe rred to in paragraph 7. 
9. If one or more competent authorities of  other concerned Member States have not 
approved the assessment report and the summary of the biocidal product characteristics within four months after receipt of the documents referred to in 
paragraph 6, they shall notify the Comm ission, the applicant, the reference 
competent authority and the competent author ities of other concerned Member States 
and shall provide them with an explan atory document identifying the biocidal 
product and its specifications and setting out the grounds on which they propose to refuse to recognise, or to rest rict, the national authorisation.  
The Commission shall adopt a decision on whether the grounds set out by the 
competent authority justify refusal to r ecognise, or restriction of, the national 
authorisation in accordance with the pro cedure referred to in Article 72(3).  
If the Commission decision dismisses th e grounds presented for refusing or 
restricting the national author isation the competent authority that proposed to refuse 
to recognise the authorisati on, or to restrict the aut horisation, shall without delay 
authorise the biocidal product concerned in acco rdance with the national 
authorisation issued by the reference competent authority. 
10. As soon as the competent authorities have  taken a decision on an application for a 
national authorisation in more  than one Member State in parallel, they shall enter 
information referred to in Article 23(5), where applicable, in the Community Register 
of Biocidal Products .   
EN 52   EN Article 29 
Adjustment to local circumstances 
1. The competent authority that has received an application for mutual recognition in 
accordance with Articles 25 or 28 may, within  two months from the receipt of the 
application, propose to the a pplicant that certain conditions  referred to in points (e), 
(f), (h), (j) and (l) of Article 58(2) in the authorisation be adjusted to local circumstances, so that conditi ons for issue of an authorisa tion laid down in  Article 16 
are satisfied, and shall inform the Commission thereof, if it esta blishes that, in its 
territory, one of the foll owing conditions is met: 
(a) the target species is not present in harmful quantities; 
(b) unacceptable tolerance or resistance of  the target organism to the biocidal 
product is demonstrated; 
(c) the relevant circumstances of use, in  particular the climate or the breeding 
period of the target species, differ significantly from  those in the Member State 
where the initial evaluation was carried  out or the Member State where the 
initial national authorisation was issued, and an unchanged national 
authorisation may therefore present una cceptable risks to humans or to the 
environment.  
The competent authoritie s shall communicat e to the Commission all proposals 
concerning adjustment of conditions in national authorisations to local circumstances and the reasons for proposing adjustment. 
2. If, within 2 months, an agreement on the proposed adjustments is not reached 
between the applicant and the competent auth ority that has received an application 
for mutual recognition, that competent au thority shall without delay inform the 
Commission thereof and provide an e xplanatory document on the proposed 
adjustments identifying the biocidal product and its specifications and setting out the 
grounds on which it proposes to adjust the conditions of the nati onal authorisation.  
The Commission shall adopt a decision on the proposed adjustment of the conditions 
of the national authorisation to local circ umstances in accordan ce with the procedure 
referred to in Article 72(3). The competen t authority of the concerned Member State 
shall without delay adopt al l appropriate measures to comply with that decision. 
Article 30 
Opinion of the Agency 
1. The Commission may ask the Agency for an opinion on scien tific or technical 
matters raised by a Member State objecting to the mutual rec ognition of a national 
authorisation or seeking to adjust the authorisation to local circumstances. The 
Agency shall issue an opinion within 6 m onths from the date on which the matter 
was referred to it. 
2. Before issuing its opinion, the Agency sha ll provide the applicant or the authorisation 
holder with an opportunity to present written or oral expl anations within a specified 
time limit not exceeding one month.  
EN 53   EN The Agency may suspend the time limit referred to in paragraph 1 to allow the 
applicant or the authorisation holder to prepare the explanations. 
Article 31 
Derogation regarding certain product-types 
By way of derogation from Articles 25 and 28, co mpetent authorities of Member States may 
refuse mutual recognition of national authoris ations granted for product types 15, 17 and 23 of 
Annex V provided that such a refu sal can be justified on grounds of the prot ection of health of 
humans, animals or plants, the protection of nati onal treasures possessing artistic, historic or 
archaeological value, or the protection of industrial and co mmercial property. Competent 
authorities of Member States shall without delay inform each other and the Commission of 
any decision taken in this respect an d shall indicate the reasons thereof. 
CHAPTER VII 
COMMUNITY AUTHORISATIONS OF BIOCIDAL 
PRODUCTS  
EN 54   EN Section 1 
Granting of Community authorisations 
Article 32 
Community authorisation 
A Community authorisation issued by the Commi ssion in accordance with this Section shall 
be valid throughout the Community unless otherwise specified. It shall confer th e same rights 
and obligations in each of the Member States  as an authorisation issued by the competent 
authority of that Member State.  
Article 33 
Biocidal products for which Communi ty authorisation may be granted 
1. The Community authorisation may be grante d to the following categories of biocidal 
products: 
(a) biocidal products containing one  or more new active substances;  
(b) low-risk biocidal products.  
2. Following the report of the Commission on  the implementation of this Regulation 
referred to in Article 54(4) and in light of  the experience gained with the Community 
authorisations, the Commission may add othe r categories of biocidal products in 
paragraph 1 of this Article.  
Those measures, designed to amend non-esse ntial elements of this Regulation by 
supplementing it, shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 72(4). 
Article 34 
Submission and validation of application 
1. The person responsible for the placing of a biocidal product on the market, or his 
representative, shall submit an applicati on for a Community au thorisation to the 
Agency and inform the Agency of the name of the competent authority of the Member State of his choice which shall be responsible for the evaluation of the 
application (hereinafter referred to as 'the evaluating competent authority').  
The Agency shall, within one month after the receipt of the a pplication, notify the 
evaluating competent authority that the a pplication is available in the Agency 
database. 
2. Within two months after th e receipt of an application, the Agency shall validate the 
application if it complies with the following requirements:  
(a) the information referred to in Article 18 has been submitted;  
EN 55   EN (b) it is accompanied by the fees payable under Article 70. 
The validation shall not include an assessmen t of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 
3. If the Agency considers that the applic ation is incomplete, it shall inform the 
applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.  
The Agency shall, within two months from  the receipt of the additional information, 
determine whether the additional informati on submitted is sufficient to validate the 
application. 
The Agency shall reject the application if the applicant fails to complete his 
application within the deadline and inform the applicant and the evaluating competent authority thereof. In such cases a part of the fee paid to the Agency in 
accordance with Article 70 shall be reimbursed. 
4. An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the third subparagraph of paragraph 3.  
5. If the Agency, on the basis of the valida tion made pursuant to paragraph 2, considers 
that the application is complete, it shall without delay inform the applicant and the 
evaluating competent authority thereof. 
Article 35 
Evaluation of applications 
1. The evaluating competent authority shall, within twelve months  after the validation, 
evaluate the dossiers in accordance with  Article 16 including, where relevant, any 
proposal to adapt data requirements su bmitted in accordance with Article 19(2). 
The evaluating competent authority shall prov ide the applicant with an opportunity to 
provide written or oral co mments on the conclusions of the evaluation within one 
month. The evaluating competent authority sh all take due account of these comments 
when finalising its evaluation. 
The evaluating competent authority shall se nd the conclusions of the assessment and 
the assessment report to the Agency. 
2. If, when the dossiers are ev aluated, it appears that additi onal information is necessary 
to carry out the evaluation, the evaluating co mpetent authority shall ask the applicant 
to submit such information within a specified  time limit, and shal l inform the Agency 
thereof.  
The twelve-month period referred to in pa ragraph 1 shall be suspended from the date 
of issue of the request until the date the information is received.  
EN 56   EN 3. Within nine months from the receipt of th e conclusions of the evaluation, the Agency 
shall prepare and submit to the Commission an  opinion on the au thorisation of the 
biocidal product.  
If the Agency recommends the authorisa tion of the biocidal product, the opinion 
shall contain at least the following elements: 
(a) a statement on whether the conditions of points (b), (c) and (d) of Article 16(1) 
are fulfilled, and a draft summary of th e biocidal product characteristics, as 
referred to in Article 20(2); 
(b) where relevant, details of any terms or conditions which should be imposed on 
the placing on the market or use of the biocidal product; 
(c) the final assessment report on the biocidal product. 
4. On receipt of the opinion of the Agenc y, the Commission shall adopt a decision on 
the Community authorisation of the bi ocidal product in accordance with the 
procedure referred to in Article 72(3).  As soon as the Co mmission has taken a 
decision to grant a Community authorisation, it shall enter the information referred to 
in Article 23(5) in the Community Register of  Biocidal Products . 
The Commission may, on the request of a Memb er State, decide that the Community 
authorisation shall not  apply in the territory of that  Member State for a biocidal 
product of the product-types 15, 17 or 23 of Annex V provided that such a request 
can be justified on grounds of the protection of health of humans, animals or plants, 
the protection of national treasures possessi ng artistic, historic or archaeological 
value, or the protection of i ndustrial and commercial property. 
The Commission may, on the request of a Me mber State, decide that certain 
conditions of the Community authorisation s hould be adjusted to  the different local 
circumstances in that Member State in accordance with Article 29. 
5. If the decision referred to in paragraph 4 refuses to grant a Community authorisation 
to a biocidal product because it does not fulfil the criter ia for a low-risk biocidal 
product in accordance with Article 17, the applicant may apply, if relevant, for a 
Community authorisation in accordance with point (a) of Article 33(1) or a national 
authorisation in accordance with Chapter V. 
6. The competent authority that has been notif ied of the application for the evaluation 
as referred to in Article 34(1) may, within one month after the receipt of the notification, submit a duly substantiated request to the Commission to appoint 
another evaluating competent authority. Th e Commission shall take a decision in 
accordance with the procedure referred to in Article 72(2).  
EN 57   EN Section 2 
Renewal of Community authorisations 
Article 36 
Submission and validation of applications 
1. The authorisation holder or his representati ve shall submit an application for renewal 
of a Community authorisation to the Agency  at least 18 months  before the expiry 
date of the authorisation. 
The application shall be accompanied by the fees payable under Article 70. 
2. The Agency shall, within one month afte r the receipt of the application, notify the 
evaluating competent authority that carri ed out the initial evaluation of the 
application for Community authorisation th at the application is available in the 
Agency database. 
3. The Commission shall renew a Commun ity authorisation, provided that the 
conditions set out in Arti cle 16 are still satisfied.  
4. When applying for renewal, the applicant shall submit a list of all data relating to the 
biocidal product that have been generate d since the previous authorisation and a 
justification as to whether the conclusions of the initial assessment of the biocidal 
product are still valid.  
The evaluating competent authority that carri ed out the initial evaluation may require 
the applicant to submit the data refe rred to in the list at any time.  
5. Within two months after th e receipt of an application, the Agency shall validate the 
application if it complies with the following requirements: 
(a) information referred to paragraph 4 has been submitted; (b) it is accompanied by the fees payable under Article 70. The validation shall not include an assessmen t of the quality or the adequacy of any 
data or justifications for the adaptation of data requirements submitted. 
6. If the Agency considers that the applic ation is incomplete, it shall inform the 
applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.  
The Agency shall, within two months after the receipt of the additional information, 
determine whether the additional informati on submitted is sufficient to validate the 
application. 
The Agency shall reject the application if the applicant fails to submit the requested 
information within the deadline and shall info rm the applicant thereof. In such cases  
EN 58   EN a part of the fee paid to the Agency in accordance with Article 70 shall be 
reimbursed. 
7. An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the third subparagraph of paragraph 6.  
8. If the Agency, on basis of the validation ma de pursuant to paragraph 5, considers that 
the application is complete , it shall without delay info rm the applicant and the 
evaluating competent authority thereof. 
Article 37 
Evaluation of applications for renewal 
1. On the basis of the available information and a need to review the conclusions of the 
initial assessment of the application for Community au thorisation, th e evaluating 
competent authority that carried out the initial evaluation of the application for Community authorisation shall, within one month after the validation referred to in 
Article 36(5), decide whether a full evalua tion of the application for renewal is 
necessary 
If the evaluating competent authority decide s that a full evaluation of the application 
is necessary, the evaluation sh all be carried out in accordan ce with paragraphs 1 to 3 
of Article 35. The decision on the applica tion shall be adopted in accordance with 
paragraph 5 of this Article. 
2. If the evaluating competent authority that  carried out the initial evaluation of the 
application for Community authorisation decides that a full evaluation of the 
application is not necessar y, it shall, within twelve months after the validation, 
prepare and submit to the Agency a recommendation on the renewal of the authorisation. 
Prior to submitting the recommendation to  the Agency, the evaluating competent 
authority shall provide the applicant with an  opportunity to provi de written or oral 
comments on the recommendation within one  month. The evaluating competent 
authority shall take due account of these comments when finalising its recommendation. 
3. On the receipt of the recommendation fr om the evaluating competent authority, the 
Agency shall make it available to the comp etent authorities of other Member States 
and the applicant and allow a period of three months during which they may submit 
written comments to it. 
4. The Commission may ask the Agency for an opinion on scien tific or technical 
matters raised by a competent authority objecting to the recommendation referred to in paragraph 2. The Agency shall issue an opinion within six months from the date on which the matter was referred to it. 
5. At the end of the period referred to in pa ragraph 3 or on receipt of the opinion of the 
Agency, the Commission shall adopt a decision to renew, or to refuse to renew, the 
Community authorisation in accordance with the procedure referred to in Article 
72(3). As soon as the Commission has taken a decision, it shall update the  
EN 59   EN information referred to in Article 23(5) in the Community Register of Biocidal 
Products . 
6. Where, for reasons beyond the control of the holder of the Community authorisation, 
no decision is taken on the renewal of the authorisation befo re its expiry, the 
Commission shall grant the re newal of the Community authorisation for the period 
necessary to complete the evaluation in acco rdance with the procedure referred to in 
Article 72(2). 
CHAPTER VIII 
CANCELLATION, REVIEW AND AMENDMENTS OF 
AUTHORISATIONS 
Article 38 
Obligation for notificati on of new information 
1. If the holder of an aut horisation becomes aware of information concerning the 
authorised biocidal product or the active substance(s) it contai ns, which may affect 
the authorisation he shall wi thout delay notify the compet ent authority that granted 
the national authorisation and the Agen cy or, in the case of a Community 
authorisation, the Commission and the Agency . In particular, the following shall be 
notified: 
(a) new knowledge or information on the eff ects of the active substance or biocidal 
product for humans or the environment;  
(b) data indicating the potential of the active substance for the development of 
resistance;  
(c) new knowledge or information indicat ing that the biocidal product is not 
sufficiently effective. 
2. The competent authority that granted the national authorisation or in the case of a 
Community authorisation, the Agency, sh all examine whether the authorisation 
needs to be amended or cancelle d in accordance with Article 39.  
3. The competent authority that granted the national authorisation or in the case of a 
Community authorisation, the Agency, shall without delay notify competent 
authorities of other Member States and, where appropriate, the Commission of any 
such information it received.  
Competent authorities of Member States that have issued national authorisations for 
the same biocidal product under the mutu al recognition procedure shall examine 
whether the authorisation needs to be am ended or cancelled in accordance with 
Article 39.  
EN 60   EN Article 39 
Cancellation or amendment of an authorisation 
1. The competent authority of a Member State or, in the case of a Community 
authorisation, the Commission, may at any tim e cancel or amend an  authorisation it 
has granted in the following cases: 
(a) the requirements referred to in Article 16 are not satisfied;  (b) false or misleading information was supplied concerning the facts on the basis 
of which the authorisation was granted; 
(c) a condition included in the authoris ation has not been complied with;  
(d) the authorisation holder fails to comply  with his obligations resulting from this 
Regulation.  
2. Where the competent authority or, in th e case of a Community authorisation, the 
Commission, intends to cancel or amend an authorisation, it shall inform the 
authorisation holder thereof and give him the opportunity to submit written or oral 
comments or additional information within a specified time li mit. The evaluating 
competent authority shall take due account  of these comments when finalising its 
decision. 
3. Where the competent authority or, in th e case of a Community authorisation, the 
Commission, cancels or amends an authorisat ion in accordance with  paragraph 1, it 
shall without delay notify the authorisation holder, the competent authorities of other 
Member States and, where relevant, the Commission.  
Competent authorities which have issued authorisations for the same biocidal 
product under the mutual recognition procedur e shall, within four months, cancel or 
amend the authorisations accordingly, taki ng into account local circumstances, and 
shall notify the Commission thereof.  
In the case of disagreement between compet ent authorities of certain Member States, 
the points of disagreement shall be referre d without delay to th e Commission and the 
procedure laid down in Articles 27 and 30  shall apply mutatis mutandis . 
4. As soon as the competent authority or the Commission in the case of a Community 
authorisation, has taken a decision to can cel or amend an authorisation, it shall 
update the information referred to in Article  23(5) relating to th e biocidal product 
concerned in the Community Register of Biocidal Products . 
Article 40 
Cancellation of an authorisation at the request of the authorisation holder 
The competent authority that has granted the na tional authorisation or in case of Community 
authorisation, the Commission, shall cancel the aut horisation at the reques t of its holder, who 
shall state the reasons for such request. If such a request conc erns a Community authorisation, 
it shall be submitted to the Agency.   
EN 61   EN As soon as the competent authority or th e Commission in the case of a Community 
authorisation, has taken a decisi on to cancel an authorisation, it  shall update the information 
referred to in Article 23(5) information relatin g to the biocidal product concerned in the 
Community Register of Biocidal Products . 
Article 41 
Amendment of an authorisation at th e request of the authorisation holder 
1. The terms and conditions of an author isation shall not be  changed unless the 
authorisation has been amended by the co mpetent authority which has previously 
authorised the biocidal product concer ned, or in the cas e of a Community 
authorisation, by the Commission. 
2. An application by an author isation holder to amend the terms and conditions of an 
authorisation shall be submitted to the compet ent authorities of all the Member States 
which have previously authorised the bioc idal product concerned, or in the case of a 
Community authorisation, to the Agency.  
The application shall be accompanied by the fees payable under Article 70. 
Article 42 
Implementing measures 
The Commission shall adopt implementing measur es specifying the criteria and procedures 
related to a cancellation of an authorisation or amendments of the terms and conditions of an 
authorisation under Articles 39 to 41, including a disput e settlement mechanism.  
Those measures, designed to amend non-esse ntial elements of this Regulation by 
supplementing it, shall be adopted in accordance  with the regulatory procedure with scrutiny 
referred to in Article 72(4). 
Article 43 
Period of grace 
Notwithstanding Article 77, where th e competent authority or in the case of a biocidal product 
authorised at Community level, the Commissi on, cancels or amends an authorisation or 
decides not to renew it, it shall grant a period of  grace for the disposal, storage, placing on the 
market and use of existing stocks except in cas es where continued placing on the market or 
use of the product would constitute  an unacceptable risk to human health or the environment.  
The period of grace shall not exceed six mo nths for the placing on the market and an 
additional maximum period of twel ve months for the disposal, storage, and use of existing 
stocks of the biocidal products concerned.  
EN 62   EN Article 44 
Parallel trade 
1. A competent authority of a Member State (her einafter referred to as 'Member State of 
introduction') may grant a parallel trad e permit for a biocidal product that is 
authorised in another Member State (herei nafter referred to as 'Member State of 
origin') to be placed on the market and used  in the Member Stat e of introduction, if it 
determines that the biocidal product is su bstantially identical in composition to a 
biocidal product already authorised in that  Member State (hereina fter referred to as 
'the reference product').  
The applicant who intends to place the biocidal product on the market in the Member 
State of introduction shall s ubmit the application for a pa rallel trade permit to the 
competent authority of the Member State of introduction. 
The application shall be accompanied by all the information necessary to 
demonstrate that the biocidal product is substantially identical to the reference 
product as defined in paragraph 3. 
2. A parallel trade permit shall be granted w ithin two months from submission of an 
application. The competent authority of  the Member State of introduction may 
request from the competent authority of the Member State of  origin additional 
information necessary to determine whether the product is substant ially identical to 
the reference product. The competent authority  of the Member State of origin shall 
provide the requested information within  one month of receiving the request.  
3. A biocidal product shall be considered as substantially identical to the reference 
product if one of the following conditions is met: 
(a) the source of the active substances it contains is the same in terms of 
manufacturer and location of the production plant;  
(b) it is either the same or similar with regard to the non-active substances present 
and the type of formulation;  
(c) it is either the same or  equivalent in terms of th e potential adverse impact on 
the safety of the product with regard to human or animal health or the 
environment. 
4. An application for a parallel trade permit shall include the following information and 
items:  
(a) name and authorisation number of the biocidal product in the Member State of 
origin; 
(b) the competent authority of the Member  State of origin that authorised the 
reference product;  
(c) name and address of the authorisatio n holder in the Member State of origin;  
EN 63   EN (d) original label and instructions for use with which the biocidal product is 
distributed in the Member State of origin if it is considered as necessary for the 
examination by the competent authority of  the Member State of introduction;  
(e) name and address of the applicant;  (f) name to be given to the biocidal pro duct to be distributed in the Member State 
of introduction; 
(g) a draft label for the product intended to be placed on the market in the Member 
State of introduction; 
(h) a sample of the product which is intended to be introduced if it is considered as 
necessary by the competent authority of the Member State of introduction; 
(i) name and authorisation number of th e reference product in the Member State 
of introduction. 
The competent authority of the Member  State of introduction may require a 
translation of the relevant parts of the orig inal instructions for the use referred to in 
point (d).  
5. The parallel trade permit shall prescr ibe the same conditions for placing on the 
market and use as the authorisat ion of the reference product.  
6. The parallel trade permit sh all be valid for the durati on of authorisation of the 
reference product in the Memb er State of introduction.  
If the authorisation holder  of the reference product applies for cancellation of 
authorisation in accordance with Article 40 and the requirements of Article 16 are 
still fulfilled, the validity of the parallel trade permit shall expire on the date on which the authorisation of the refere nce product would have normally expired. 
7. Without prejudice to specific provisions in this Article, Articles 38 to 41 and Chapter 
XIII shall apply mutatis mutandis to biocidal products placed on the market under a 
parallel trade permit. 
8. The competent authority of the Member State of introduction may withdraw a 
parallel trade permit if the authorisati on of the introduced biocidal product is 
withdrawn in the Member State of origin because of safety or efficacy reasons. 
9. Where a decision concerning the application for a parallel trade permit is taken in 
accordance with the provisions of this Arti cle, the competent authorities of Member 
States which have taken such a decision sh all enter the information referred to in 
Article 23(5) in the Community Register of Biocidal Products .  
EN 64   EN CHAPTER IX 
DEROGATIONS 
Article 45 
Derogation from the requirements  
1. By way of derogation from Articles 15 a nd 16, a competent authority may authorise 
for a period not exceeding nine months, the placing on the market of a biocidal product not complying with the provision s of this Regulation for a limited and 
controlled use if such a measure is necessary  because of a danger to public health or 
the environment which cannot be contained by other means.  
The competent authority referred to in the first subparagraph shall without delay 
inform the other competent authorities and the Commission of  its action and the 
justification for it. The competent author ity shall without delay inform the other 
competent authorities and the Commissi on of a revocation of such action. 
The Commission shall without delay decide whether, and under what conditions, the 
action taken by the competent authority ma y be extended for a period not exceeding 
18 months in accordance with the pro cedure referred to in Article 72(3).  
2. By way of derogation from point (a) Article 16(1) and un til an active substance is 
listed in Annex I, competent authorities and the Commission may authorise, for a period not exceeding three years, the plac ing on the market of a biocidal product 
containing a new active substa nce not listed in Annex I.  
Such an authorisation may be issued only if, after dossiers have  been evaluated in 
accordance with Article 8, the evaluati ng competent authority has submitted a 
recommendation for inclusion of the new active substance in  Annex I and the 
competent authority which received the appl ication for the provisional authorisation 
or in case of Community authorisation, the Agency, c onsiders that the biocidal 
product may be expected to comply with  points (c) and (d) of Articles 16(1). 
The competent authorities or the Commi ssion shall enter the information on the 
authorisation referred to in Article 23(5) in the Community Register of Biocidal 
Products . 
If the Commission decides not to include  an active substance in Annex I, the 
competent authority which granted an authorisation referred to in the first subparagraph or the Commission sha ll cancel that authorisation. 
Where a decision on the inclusi on of an active substance in Annex I has not yet been 
adopted by the Commission when the period of three years expires, the competent 
authority which granted a provisional au thorisation, or the Commission, may extend 
the provisional authorisation for a period not exceeding one year, provided there are 
good reasons to believe that the active substance will satisfy the requirements of Article 4. Competent authorities which ex tended the provisional authorisation shall 
inform the other competent authorities and, where appropriate , the Commission of 
such action.  
EN 65   EN 3. In addition to the active substances refe rred to in Article 15(2 ) of Regulation (EC) 
No 1907/2006, active substances manufactured  or imported for use in biocidal 
products which are authorised for placing on the market in accordance with this Article shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the 
requirements of Chapters 1 and 5, Ti tle II of Regulation (EC) No 1907/2006. 
Article 46 
Research and development 
1. By way of derogation from Article 15 , an experiment or a test for the purposes of 
research or development involving the pl acing on the market of an unauthorised 
biocidal product or an active substance in tended exclusively for use in a biocidal 
product may only take place in the case of sc ientific research and development or in 
the case of product and process-oriented research and development, and under the conditions laid down in the s econd and third subparagraphs. 
In the case of scientific re search and development, the person who intends to carry 
out the experiment or the test shall notify the competent authority prior to the start. The person shall draw up and maintain wri tten records detailing the identity of the 
biocidal product or active substance, la belling data, quantities supplied and the 
names and addresses of those persons r eceiving the biocidal product or active 
substance, and shall compile a dossier containing all available data on possible 
effects on human or animal health or impact on the environment. The persons concerned shall, if requested, make this information available to the competent authority . 
In the case of product and process-oriented  research and development, the person 
who intends to carry out the experiment or the test shall, prior to the placing of the 
biocidal product or the active substan ce on the market, notify the information 
required in the second subparagraph to the competent authority of the Member State 
where the placing on the market occurs . 
2. An unauthorised biocidal product or an active substance for exclusive use in a 
biocidal product shall not be placed on the market for the purpose of any experiment 
or test which may involve, or result in, re lease of the biocidal  product into the 
environment unless the competent authority has assessed the data submitted by the 
person interested in the placing of such product on the market and issued a national 
authorisation for this purpose which limits th e quantities to be used and the areas to 
be treated and which may impose further conditions. The competent authority shall 
without delay inform the Commission and other competent authorities about the 
issued national authorisation. 
3. Where any experiment or test takes place in a Member State other than the Member 
State where placing on the market of the bi ocidal product occurs, the applicant shall 
obtain experiment or test au thorisation from the competent authority of the Member 
State in the territory of which the expe riments or tests are to be conducted. 
If the proposed experiments or tests refe rred to in paragraphs 1 and 2 may have 
harmful effects on human or animal health  or any unacceptable adverse effect on the  
EN 66   EN environment, the competent authority of the Member State concerned may prohibit 
them or allow them subject to such conditions as it considers necessary to prevent those consequences. The competent authority shall without delay inform the Commission and other competent au thorities about such measures. 
4. The Commission shall adopt measures to  specify the overall applicable maximum 
quantities of active substances or biocidal  products that may be released during 
experiments and the minimum data to be submitted in accordance with paragraph 2.  
Those measures designed to amend non-esse ntial elements of this Regulation by 
supplementing it shall be adopted in accord ance with the regulatory procedure with 
scrutiny referred to in Article 72(4). 
CHAPTER X 
TREATED ARTICLES OR MATERIALS 
Article 47 
Placing on the market of t reated articles or materials 
1. Treated materials or articles that incorpor ate one or more biocidal products shall not 
be placed on the market unless the biocidal product(s) used for treating the materials 
or articles are authorised for this use in  the Community or in at least one Member 
State. 
2. Treated articles or materials shall be labelled with the following information: 
(a) the name of all active substances that we re used to treat the article or materials 
or that were incorporated in the articles or materials;  
(b) where relevant, the biocidal property attr ibuted to treated articles or materials; 
(c) the authorisation number of all biocid al products that were used for the 
treatment or were incorporated in the articles or materials; 
(d) any hazard statement or precautionary st atement set out in the authorisation for 
the biocidal product. 
The labelling shall be clearly visible, easily legible and appropriately durable. Where this is necessary because of the size or the function of th e treated article or 
material, the labelling shall be printed on the packaging, on the instructions for use or 
on the warranty of the treated article or material.  
EN 67   EN CHAPTER XI 
DATA PROTECTION AND DATA-SHARING 
Article 48 
Protection of information held by co mpetent authorities or the Agency 
1. Information submitted for the purposes of this Regulation shall not be used by 
competent authorities or the Agency for the benefit of a subsequent applicant, except 
in one of the following cases: 
(a) the subsequent applicant has written ag reement in the form of a letter of access 
from the first applicant that he can use that information,  
(b) the relevant time limit for data protection has expired.  
2. When an applicant submits any informa tion to a competent authority or to the 
Agency, he shall also provide a list of a ll the information submitted. In the list he 
shall specify whether he is the owner of the information or whether he only holds a 
letter of access to that information. In the la tter case, the list shall contain the name 
and contact details of the ow ner. The applicant shall inform the competent authority 
or the Agency about any changes to the ownership of the information. 
3. On receipt of the list referred to in pa ragraph 2, the competent authorities shall send 
it to the Agency.  
4. The list referred to in paragraph 2 shall be entered by the Agency in the Biocides 
Data Sharing Register .  
5. The Commission, the Agency, the adviso ry scientific committees set up under 
Commission Decision 2004/210/EC setting up Scie ntific Committees in the field of 
consumer safety, public health and the environment45 and the competent authorities 
shall have access to the informa tion referred to in paragraph 1. 
Article 49 
Information protection periods 
1. Information submitted for the purposes of Directive 98/8/EC or of this Regulation 
shall benefit from data protection under the conditions laid down in this Article. The 
protection period for this information shall start when the information is submitted. 
Information protected under Di rective 98/8/EC or under this  Article or for which the 
protection period expired under Directive 98/8/EC or under th is Article shall not be 
protected again.  
                                                 
45 OJ L 66, 4.3.2004, p. 45  
EN 68   EN 2. The protection period for information submitted in view of the inclusion of an 
existing active substance in Annex I shall e nd 10 years from the date of the inclusion 
of the relevant active substance in A nnex I for the particular product-type.  
The protection period for information submitted in view of the inclusion of a new 
active substance in Annex I sh all end 15 years from the date  of the inclusion of the 
relevant active substance in Annex I for the particul ar product-type.  
The protection period for information submitte d in view of the renewal or review of 
the inclusion of an active substance in Anne x I shall end 5 years from the date of the 
decision concerning the renewal or the review being taken 
3. The protection period for information submitted in view of the authorisation of a 
biocidal product containing only existing active substances  shall end 10 years from 
the date of the first auth orisation of the product. 
The protection period for information submitted in view of the authorisation of a 
biocidal product containing a new active su bstance shall end 15 years from the date 
of the first authorisation of the product. 
The protection period for information submitted in view of the renewal or 
amendment of the authorisation of a biocid al product shall end 5 years from the date 
of the renewal or amendm ent of the authorisation. 
4. By way of derogation from the first s ubparagraph of paragraph 2, the protection 
period for information submitted to a Me mber State under national systems or 
practices for the approval of biocidal products, before it was submitted for the purposes of Directive 98/8/EC or of this Regulation, shall end at the expiry of any 
remaining period provided for under nationa l rules or on 14 May 2014, whichever is 
the earlier, unless this information has been generated after 14 May 2000.  
Article 50 
Letter of access 
1. A letter of access shall contain at least the following information: 
(a) name and contact details of th e data owner and the beneficiary; 
(b) date on which the letter of access takes effect and its expiry date; 
(c) the submitted information to which the letter of access grants citation rights; 
(d) the address of the manufacturing facili ty where the active substance or biocidal 
product is produced;  
(e) the conditions under which it may be revoked.  
2. Revocation of a letter of access prior to its expiry date shall not affect the validity of 
the authorisation issued on the basis of the letter of access in question.  
EN 69   EN Article 51 
Mandatory information sharing 
1. In order to avoid animal te sting, testing on vertebrate anim als for the purposes of this 
Regulation shall be undertaken only as a la st resort. Testing on vertebrate animals 
shall not be repeated for the purposes of this Regulation.  
2. Any person intending to perf orm tests or studies involvi ng vertebrate animals or non-
vertebrate animals, hereinafter "the pros pective applicant", shall ask the competent 
authority or the Agency whether such tests or studies have already been submitted in connection with a previous a pplication. The competent authority or the Agency shall 
verify if there is any data on such tests or studies in the Biocides Data Sharing Register. 
Where those tests or studies have alre ady been submitted in connection with a 
previous application, the co mpetent authority or the Agency shall without delay 
communicate the name and contact details of  the owner of the information to the 
prospective applicant.  
Where the data acquired under those tests or studies are still protected under Article 
49, and involve tests on vertebrate animal s the prospective app licant shall request 
from the owner of the information the righ t to refer to the tests or studies.  
Where the data acquired under those tests or studies are still protected under Article 
49, and do not involve tests on vertebrate animals, the prospective applicant may 
request from the owner of the information th e right to refer to the tests or studies.  
Article 52 
Compensation for mandatory information sharing 
1. Where a request has been made in accord ance with Article 51(2), the prospective 
applicant and the owner of the informati on shall make every effort to reach an 
agreement on the sharing of the results of  the tests or studies requested by the 
prospective applicant. Such  an agreement may be repl aced by submission of the 
matter to an arbitration body and a commi tment to accept the arbitration order. 
2. Where such agreement is reached, the owne r of the information shall make available 
to the prospective applicant the informati on and shall give the prospective applicant 
the permission to refer to the data owner's tests or studies.  
3. Where no such agreement is reached tw o months after the request was made 
according to Article 51(2), the prospective applicant shall without delay inform the 
Agency and the owner of the information thereof. Within two months of being informed about the failure to reach an agreement, the Agency shall give the prospective applicant the righ t to refer to the tests or  studies involving tests on 
vertebrate animals. National courts shall de cide on the proportionate share of the cost 
that the prospective applicant sh all pay to the data owner.  
4. The costs of sharing the test s or studies shall be determined in a fair, transparent and 
non-discriminatory manner.  
EN 70   EN 5. An appeal may be brought, in accordance with Article 67, against Agency decisions 
under paragraph 3 of this Article.  
Article 53 
Use of data for subsequent applications for authorisations 
1. In the case of a biocidal product which ha s already been authorised in accordance 
with Articles 15, 25 or 28, and where all periods of protection of information 
according to Article 49 have expired, th e receiving competent authority or the 
Agency may agree that a subsequent appli cant for authorisation may refer to data 
provided by the first applican t in so far as the subse quent applicant can provide 
evidence that the biocidal product is similar to and its active substances are 
technically equivalent to the one formerly authorised, including degree of purity and 
nature of impurities. 
An appeal may be brought, in accordance with Article 67, against Agency decisions 
under the first subparagraph of this paragraph.  
2. Notwithstanding paragraph 1, subsequent applicants shall provide the following 
information accordingly to the receivi ng competent authority or the Agency: 
(a) all necessary data for the identificati on of the biocidal product, including its 
composition; 
(b) the information needed to identify the active substance and to establish 
technical equivalence of  the active substance; 
(c) all necessary data for the evaluation of  substances of concern contained in the 
biocidal product; 
(d) the data needed to demonstrate that the biocidal product has comparable 
efficacy to the biocidal product formerly authorised in accordance with Articles 15, 25 or 28. 
CHAPTER XII 
INFORMATION AND COMMUNICATION  
EN 71   EN Section 1 
Monitoring and reporting 
Article 54 
Compliance with requirements 
1. Competent authorities shall take the neces sary arrangements for biocidal products 
which have been placed on the market on their own or incor porated in treated 
materials to be monitored to establish whet her they comply with the requirements of 
this Regulation. Regulation (EC) No 765/2008 of  the European Parliament and of the 
Council setting out the requirements for accreditation and market surveillance 
relating to the marketing of products and repealing Regulation (EEC) No 339/9346 
shall apply accordingly. 
2. Competent authorities shall carry out offici al controls in order to enforce compliance 
with this Regulation.  
3. Every three years, starting in 2013, competent authorities shall submit to the 
Commission a report on the implementation of this Regulation in their respective 
territories. The report shall include: 
(a) information on the results of official controls carried out in accordance with 
paragraph 2; 
(b) information on any poisonings  involving biocidal products. 
4. The Commission shall draw up a report on the implementation of this Regulation 
and, in particular, on the functioning of th e Community authorisation procedure and 
mutual recognition, by 1 January 2023. The Commission shall submit the report to 
the European Parliament and the Council.  
Article 55 
Confidentiality 
1. Regulation (EC) No 1049/2001 of the Euro pean Parliament and of the Council 
regarding public access to  European Parliament, Council and Commission 
documents47 and the rules of the Management Board of the Agency, adopted in 
accordance with Article 118(3) Regulati on (EC) No 1907/2006, shall apply to 
documents held by the Agency for the purposes of this Regulation.  
2. Disclosure of the following information shall be deemed to undermine the protection 
of the commercial interest s of the concerned person: 
(a) details of the full compos ition of a biocidal product; 
                                                 
46 OJ L 218, 13.8.2008, p. 30 
47 OJ L 145, 31.5.2001, p. 43.  
EN 72   EN (b) the precise use, function or appli cation of a substance or mixture;  
(c) the precise tonnage of the substance or mixture manufactured or placed on the 
market; 
(d) links between a manufacturer of an active substance and the person responsible 
for the placing of a biocidal produc t on the market or between the person 
responsible for the placing of a bi ocidal product on the market and 
thedistributors of the product. 
However, where urgent action is essential to protect human health, safety or the 
environment, the Agency or the competent authorities may disclose the information referred to in this paragraph. 
3. Any person submitting information related to an active substance to the Agency or a 
competent authority for the purposes of this Regulation can request that the information in Article 56(2) shall not be made  available including a justification as to 
why the disclosure of the information could be harmful for his or any other 
concerned party's commercial interests. 
4. Information accepted as confidential by a comp etent authority or the Agency shall be 
treated as confidential by the other comp etent authorities, the Agency and the 
Commission. 
Article 56  
Electronic public access 
1. The following information held by the co mpetent authorities, the Agency or, as 
appropriate, the Commission on active substa nces shall be made, free of charge, 
publicly available: 
(a) without prejudice to point (e) of paragr aph 2 of this Article, the name in the 
International Union of Pure and Applie d Chemistry (IUPAC) nomenclature for 
active substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC)  No 1272/ 2008: 
(i) hazard classes 2.1 to 2.4, 2.6 a nd 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 
2.13 categories 1 and 2, 2.14 categorie s 1 and 2, 2.15 types A to F; 
(ii) hazard classes 3.1 to 3.6, 3.7 a dverse effects on sexual function and 
fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10; 
(iii) hazard class 4.1; (iv) hazard class 5.1;  
(b) if applicable, the name of the active substance as given in European Inventory 
of Existing Commercial Chem ical Substances (EINECS); 
(c) the classification and labell ing of the active substance;  
EN 73   EN (d) physicochemical data concerning the active substance and data on pathways 
and environmental fate; 
(e) the result of each toxicologi cal and ecotoxicological study; 
(f) acceptable exposure level or  predicted no-effect conc entration established in 
accordance with Annex VI to this Regulation; 
(g) the guidance on safe use provided in accordance with Annex II and Annex III 
to this Regulation; 
(h) analytical methods if requested in accordance with Annex II or III to this 
Regulation which make it possible to detect a dangerous substance when 
discharged into the environment as well as to determine the direct exposure of humans. 
If the information listed in the first subpara graph concerns a new active substance, it 
shall be made publically available only afte r the date on which the inclusion of the 
new active substance in Annex I to this Regulation becomes effective. 
2. The following information on active substanc es whether on their own, in mixtures or 
in materials or articles, or information on biocidal products shall be made publicly 
available, free of charge, except where a party submitting the information submits a 
justification in accordance with Article 55(3), accepted as valid by the competent 
authority, the Agency or, as appropriate, the Commission, as to why such publication 
is potentially harmful for the commercial inte rests of the applicant or any other party 
concerned:  
(a) if essential to classification and labe lling, the degree of purity of the substance 
and the identity of impurities and/or  additives which are known to be 
dangerous; 
(b) the study summaries or robust study su mmaries of the information referred to 
in paragraph 1(d) and (e) of this Article; 
(c) information, other than that listed in paragraph 1 of this Article, contained in 
the safety data sheet; 
(d) the trade name(s) of the substance; (e) subject to Article 24  of Regulation (EC) No 1272/2008, the name in the 
IUPAC nomenclature for active substances re ferred to in paragraph 1(a) of this 
Article that are only used as one or more of the following: 
(i) in scientific research and development; (ii) in product and process orient ated research and development. 
3. After the authorisation has been granted, confidentiality shall not in any case apply 
to: 
(a) the name and address of the applicant;  
EN 74   EN (b) the name and address of th e biocidal product manufacturer; 
(c) the name and address of th e active substance manufacturer; 
(d) the content of the active substance or s ubstances in the bioc idal product and the 
name of the biocidal product; 
(e) physical and chemical data concerning the biocidal product; 
(f) any ways of rendering the active s ubstance or biocidal product harmless; 
(g) a summary of the results of the tests re quired pursuant to Article 18 to establish 
the product's efficacy and effects on huma ns, animals and the environment and, 
where applicable, its ability to promote resistance; 
(h) recommended methods and precautions  to reduce dangers from handling, 
storage, transport and use as well as from fire or other hazards; 
(i) safety data sheets; (j) methods of analysis referred to  in point (c) of Article 16(1); 
(k) methods of disposal of th e product and of its packaging; 
(l) procedures to be followed and measures to be taken in the case of spillage or 
leakage; 
(m) first aid and medical advice to be gi ven in the case of injury to persons. 
Article 57 
Record-keeping and reporting 
1. Producers, importers and prof essional users of biocidal products shall keep records 
of the biocidal products they produce, place on the market or use for at least three 
years. They shall make available the releva nt information contained in these records 
to the competent authority on request.  
2. The Commission shall adopt implementing m easures to specify the form and content 
of the information in the records, and to ensure the uniform appl ication of paragraph 
1 in accordance with the procedure referred to in Article 72(3).  
EN 75   EN Section 2 
Information about biocidal products 
Article 58 
Classification, packaging and labelling of biocidal products 
1. Biocidal products shall be classified, packaged and labelled in accordance with 
Directive 1999/45/EC and, where applic able, Regulation (EC) 1272/2008 and the 
approved summary of the biocidal product ch aracteristics, in particular the hazard 
statements and the precautionary statements , as referred to in point (i) of Article 
20(2) of this Regulation. 
In addition, products which may be mistaken  for food, drink or feedingstuffs shall be 
packaged to minimise the likelihood of such a mistak e being made. If they are 
available to the general public, they sha ll contain components to discourage their 
consumption. 
2. Labels shall not be misleading and, in any case, shall not mention the indications 
‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’ or similar indications. In 
addition, the label must show clearly a nd indelibly the following information:  
(a) the identity of every active substan ce and its concentration in metric units; 
(b) the authorisation number allocated to  the biocidal product by the competent 
authority; 
(c) the type of mixture; (d) the uses for which the bioc idal product is authorised; 
(e) directions for use and the dose rate, expressed in metric units, for each use 
provided for under the terms of the authorisation; 
(f) particulars of likely direct  or indirect adverse side effects and any directions for 
first aid; 
(g) if accompanied by a leaflet, the senten ce ‘Read attached instructions before 
use’; 
(h) directions for safe disposal of the biocidal product and its packaging, including, 
where relevant, any prohibition on reuse of packaging; 
(i) the formulation batch number or desi gnation and the expiry date relevant to 
normal conditions of storage; 
(j) the period of time needed for the biocid al effect, the interval to be observed 
between applications of the biocidal product or between application and the 
next use of the product treated, or the ne xt access by man or an imals to the area 
where the biocidal product has been used, including partic ulars concerning  
EN 76   EN decontamination means and measures and duration of necessary ventilation of 
treated areas; particulars for adequa te cleaning of equipment; particulars 
concerning precautionary measures duri ng use, storage and transport;  
(k) where applicable, the categories of us ers to which the biocidal product is 
restricted;  
(l) where applicable, information on a ny specific danger to the environment 
particularly concerning protection of non-target organisms and avoidance of 
contamination of water; 
(m) for biocidal products containing micr o-organisms, labelling requirements in 
accordance with Directive 2000/54/EC. 
By way of derogation from the first subparagraph, where this is necessary because of 
the size or the function of the biocidal pr oduct, the information referred to in points 
(c), (e), (f), (h), (i), (j) and (l) ma y be indicated on the packaging or on an 
accompanying leaflet integral to the packaging.  
3. Member States may require that biocidal  products placed on the market of their 
territories are labelle d in their national language or languages. 
Article 59 
Safety Data Sheets 
The safety-data sheets shall be prepared and made available in accordance with Annex II of 
Regulation (EC) No 1907/2006, for biocidal pr oducts classified as hazardous, and in 
accordance with the requirements of Article 31 of  that Regulation, for active substances used 
exclusively in biocidal products. 
Article 60 
Community Register of Biocidal Products 
1. A Community Register for Biocidal Products  shall be established and maintained by 
the Commission. 
2. The Community Register for Biocidal Products  shall be used for the exchange of 
information between competent authorit ies, the Agency and the Commission. 
3. Applicants shall use the Community Regist er for Biocidal Produc ts to generate the 
application form for all procedures relating to the authorisation of biocidal products, 
the mutual recognition and the parallel trade permit. 
4. Competent authorities shall update in the Community Register for Biocidal Products 
the information relating to biocidal products which have been authorised within their 
territory or for which a national authorisa tion has been refused, amended, renewed or 
cancelled. The Commission shall update the in formation relating to  biocidal products 
which have been authorised in the Community or for which a Community 
authorisation has been refused, amended, renewed or cancelled.  
EN 77   EN 5. The Commission may adopt detailed rules on the types of information to be entered 
in the Community Register for Biocidal Produ cts and the procedures related to it, in 
accordance with the procedure referred to in Article 72(2). 
Article 61 
Biocides Data Sharing Register 
1. The Biocides Data Sharing Register sh all be established and maintained by the 
Agency.  
2. The Biocides Data Sharing Register sha ll contain information provided by competent 
authorities and the Agency in accordance with paragra phs 3 and 4 of Article 48.  
The Register shall only be accessible to competent authorities, the Agency and the 
Commission. Competent authorit ies and the Agency shall re spond to all enquiries by 
prospective applicants concerning inform ation contained in the Biocides Data 
Sharing Register in order to facilitate sh aring of information and shall on request 
provide the contact details of the owne r of the information in question and a 
statement whether and for how long the info rmation is subject to data protection 
under this Regulation. 
Article 62 
Advertising 
1. Any advertisement for biocidal products shall be accompanied by the sentences ‘Use 
biocides safely. Always read the label and product information before use’. The 
sentences shall be clearly di stinguishable in relation to  the whole advertisement. 
2. Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear 
reference to the product-type as se t out in Annex V being advertised. 
3. Advertisements for biocidal products shall not refer to the product in a manner which 
is misleading in respect of the risks fr om the product to human health or the 
environment. In any case, the advertising of a biocidal product shall not mention 
‘low-risk biocidal product’,  ‘non-toxic’, ‘harmless’ or any similar indication.  
Article 63 
Poison control 
1. Member States shall appoint a body or bodies responsible for receiving information 
on biocidal products which have been placed  on the market, including information on 
the chemical composition of such products, and for making such information available in cases where suspected pois oning arises from biocidal products.  
Member States may decide to appoint th e body or bodies that have already been 
appointed in accordance with Article 45 of Regulation (EC) No 1272/2008 to carry 
out the tasks under this Article.  
EN 78   EN 2. The bodies appointed by the Member States  shall provide all the requisite guarantees 
for maintaining the confidentiality of the information received. Such information may only be used for the following purposes: 
(a) to meet medical demand by formulating preventive and curative measures, in 
particular in case of emergency; 
(b) where requested by the Member State, to undertake statistical analysis to 
identify where improved risk management measures may be needed.  
CHAPTER XIII 
THE AGENCY 
Article 64 
Role of the Agency 
The Agency shall carry out the tasks conferred on it by Chapters II, III, IV, VI, VII, VIII, IX, 
X, XI, XII and XIV of this Regulation. 
Article 65 
Biocidal Products Committee 
1. A Biocidal Products Committee is hereby established within the Agency. 
The Biocidal Products Committ ee shall be responsible fo r preparing the opinion of 
the Agency on the following issues:  
(a) applications for inclusion and renewa l of inclusion of active substances in 
Annex I; 
(b) review of inclusion of ac tive substances in Annex I;  
(c) identification of active substances which are candidates for substitution;  (d) applications for Community  authorisation of biocidal  products and for renewal, 
cancellation and amendments of Community authorisation;  
(e) scientific and technical matters in th e case of objections to mutual recognition; 
(f) any other questions that arise from th e operation of this Regulation relating to 
risks to human health or the environment.  
2. Articles 85, 87 and 88 of Regulati on (EC) No 1907/2006 concerning the 
establishment, the composition and the qua lification and interests of the Committee 
for Risk Assessment shall apply mutatis mutandis to the Biocidal Products 
Committee. 
The Biocidal Products Committee may establis h working groups and delegate certain 
tasks to those working groups.  
EN 79   EN The members of the Biocidal Products Committee shall be supported by the 
scientific and technical resources availabl e to the Member States. Member States 
shall provide adequate scientific and t echnical resources to the members of the 
Biocidal Products Committee that they ha ve nominated. Competent authorities of 
Member States shall facilita te the activities of  the Biocidal Products Committee and 
their working groups. 
Article 66 
Operation of the Biocidal Products Commi ttee and the Secretariat of the Agency 
1. Articles 78 to 84, 89 and 90 of Regu lation (EC) No 1907/2006 shall apply mutatis 
mutandis taking into account the role of the Agen cy with respect to this Regulation.  
2. The Secretariat of the Agency referred to in point (g) of Article  76(1) of Regulation 
(EC) No 1907/2006 shall undertake the following tasks: 
(a) establishing and maintaining the Biocides Data Sharing Register; (b) performing the tasks relating to the valida tion of the applications referred to in 
Articles 7(3), 11(3) and 34(2) of this Regulation; 
(c) providing technical and scie ntific guidance and tools for the application of this 
Regulation by the Commission and the co mpetent authorities of Member 
States; 
(d) providing advice and assistance to app licants for the inclusion of an active 
substance in Annex I or for a Community authorisation; 
(e) preparing explanatory information on this Regulation; (f) establishing and maintaining database(s) with information on active substances 
and biocidal products; 
(g) at the request of the Commission, providi ng technical and scientific support to 
improve cooperation between the Comm unity, the competent authorities, 
international organisations a nd third countries on scien tific and technical issues 
relating to biocidal products; 
(h) notification of decisi ons taken by the Agency; 
(i) provision of formats for submissi on of information to the Agency. 
3. The Secretariat shall make the information identified in Article 56(1) and (2) in the 
database(s) publicly available, free of ch arge, over the Internet, except where a 
request made under Article 55(3) is considered justified. The Agency shall make other information in the databases availabl e on request in accorda nce with Article 55.  
EN 80   EN Article 67 
Appeal 
1. An appeal against decisions of the Agen cy taken pursuant to Articles 7(4), 11(4), 
34(3), 36(6), 52(3) and 53(1) shall lie with the Board of Appeal. 
Articles 92(1) and (2), 93 and 94 of Regul ation (EC) No 1907/2006 shall apply to 
appeal procedures lodge d under this Regulation. 
A fee may be payable by a person bringi ng an appeal in accordance with Article 
70(2) of this Regulation. 
2. An appeal lodged pursuant to paragraph 1 shall have suspensive effect. 
Article 68 
The budget of the Agency 
1. For the purposes of this Regulation, the revenues of the Agency shall consist of: 
(a) a subsidy from the Community, entered in the general budget  of the European 
Communities (Commission Section); 
(b) the fees paid by undertakings; (c) any charges paid to the Agency for services provided under this Regulation; 
(d) any voluntary contribution from the Member States. 
2. Revenue and expenditure for activities relate d to this Regulation and those relating to 
activities under Regulation (E C) No 1907/2006 shall be dealt with separately in the 
Agency’s budget with a separate budgetary and accounting reporting. 
Revenue of the Agency referred to in Ar ticle 96(1) of Regulation (EC) No 1907/2006 
shall not be used for carrying out tasks under this Regulation. 
Article 69 
Formats and software for submission of information to the Agency 
The Agency shall specify formats and make them  available free of charge, and shall specify 
software packages and make them available on its website for submissions to the Agency. The 
competent authorities and applicants shall use these formats and packages in their 
submissions to the Agency pursuant to this Regulation.  
The format of the technical dossier referred to in Articles 6(1), 11(1), 18 and 36(4) shall be 
IUCLID.  
EN 81   EN CHAPTER XIV 
FINAL PROVISIONS 
Article 70 
Fees and charges 
1. The Commission shall esta blish rules concerning: 
(a) the system of fees payable to the Agency;  (b) the harmonised structure of fees; (c) the circumstances under which a proportion of the fees is to be transferred to 
the competent authority of the evaluating Member State; 
(d) the partial reimbursement of the fee in cases the applicant fails to submit the 
information requested within the deadlin e during validation of the application.  
Those measures, designed to amend non-esse ntial elements of this Regulation by 
supplementing it, shall be adopted according to the regulatory procedure with scrutiny referred to in Article 72(4).  
2. The harmonised structure of fees and conditions of payment shall be based on the 
following principles: 
(a) a reduced fee shall be set for small and medium-sized enterprises within the 
meaning of Recommendation 2003/361/EC concerning the definition of micro, 
small and medium-sized enterprises
48; 
(b) the fee structure shall take into  account whether information has been 
submitted jointly or separately; 
(c) in duly justified circumstances and where it is accepted by the competent 
authority or the Agency, it shall be possible to waive the fee;  
(d) an annual fee shall be paid by person s placing biocidal products on the market; 
and 
(e) the structure and amount of the fees sh all take account of the work required by 
this Regulation to be carried out by the Agency and the competent authorities and shall be fixed at such level as to ensure that the revenue derived from the 
fees when combined with other sources  of the Agency's revenue pursuant to 
this Regulation is sufficient to cover the cost of the services delivered.  
3. Member States shall oblige those who have  placed or are seeking to place biocidal 
products on the market and those supporting in clusion of active substances in Annex 
                                                
 
48 OJ L 124 of 20.5.2003, p. 36  
EN 82   EN I to pay fees in accordance with the harmoni sed structure of fees and conditions of 
payment to be adopted in accordance with paragraph 1.  
4. In accordance with the rules referred to in  paragraph 1, the Agency shall oblige those 
who have placed or are seeking to place bi ocidal products on the market and those 
supporting inclusion of active substances in  Annex I to pay fees. The structure and 
the amount of fees payable to the Agency shall be determined in accordance with 
paragraph 1. 
The Agency may collect charges for other services it provides. 
Article 71 
Competent authorities 
1. Member States shall designate a compet ent authority or competent authorities 
responsible for the applica tion of this Regulation.  
Member States shall inform the Commi ssion of the names and addresses of the 
designated competent authorities by 1 Janua ry 2013. Member States shall, without 
undue delay, inform the Commission of a ny changes to the names and addresses of 
the competent authorities. 
2. The Commission shall make publicly availabl e the list of the competent authorities. 
Article 72 
Standing Committee  
1. The Commission shall be assisted by th e Standing Committee on Biocidal Products. 
2. Where reference is made to this pa ragraph, Articles 3 and 7 of Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 
3. Where reference is made to this pa ragraph, Articles 5 and 7 of Decision 
1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three 
months. 
4. Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of 
Decision 1999/468/EC shall apply, having re gard to the provisions of Article 8 
thereof. 
5. Where reference is made to this paragraph, Article 5a (1), (2), (4) and (6), and Article 
7 of Decision 1999/468/EC shall apply, having regard to the provis ions of Article 8 
thereof. 
Article 73 
Adaptation to scientific and technical progress 
The Commission may adapt the Annexes to scientific and tec hnical progress.   
EN 83   EN Those measures, designed to amend non-essen tial elements of this Regulation, shall be 
adopted in accordance with the regulatory procedure w ith scrutiny referred to in Article 72(4).  
Article 74 
Updating of Annex I 
By 1 January 2013, the Commission shall, in acco rdance with the proce dure referred to in 
Article 72(3), amend Annex I with effect from the date of applicability of this Regulation in order to take into account any amendment to Annex I adopted under Directive 98/8/EC since the entry into force of this Regulation. 
Article 75 
Penalties 
Member States shall lay down the provisions on pe nalties applicable to infringement of the 
provisions of this Regulation and shall take all measures necessary to ensure that they are 
implemented. The penalties provided for must be  effective, proportionate and dissuasive. The 
Member States shall notify those provisions to the Commission no later than 1 December 
2015 and shall notify the Commissi on without delay of any subs equent amendment affecting 
them. 
Article 76 
Safeguard clause 
Where, based on new evidence, a Member State has justifiable grounds to consider that a 
biocidal product, although satisfy ing the requirements of this Regulation, constitutes a serious 
risk to human or animal health or to the e nvironment, it may take appropriate provisional 
measures. The Member State shall without delay inform the Commission and the other 
Member States thereof and give reasons fo r its decision based on the new evidence.  
The Commission shall, in accordance with the pro cedure referred to in Article 72(3), either 
authorise the provisional measur e for a time period defined in the decision or require the 
Member State to revoke the provisional measure.  
Article 77 
Transitional measures  
1. The Commission shall carry on with the work programme for the systematic 
examination of all existing active substan ces commenced in accordance with Article 
16(2) of Directive 98/8/EC and achieve  it by 14 May 2014. The Commission may 
adopt implementing rules to carry out the wo rk programme and to specify the related 
rights and obligations of the competent au thorities and the participants in the 
programme. Those measures, designed to amend non-essential elements of this 
Regulation by supplementing it, shall be a dopted in accordance with the regulatory 
procedure with scrutiny refe rred to in Article 72(4). 
Depending upon the progress of the work programme, the Commission may extend 
the duration of the work programme for a de termined period. That measure, designed  
EN 84   EN to amend non-essential elements of this  Regulation by supplementing it, shall be 
adopted in accordance with the regulatory procedure with scrutiny referred to in 
Article 72(4). 
During the work programme, the Commission shall decide pursuant to the procedure 
laid down in Article 72(4) that an active substance shall be in cluded in Annex I of 
this Regulation and under which conditions, or, in cases where the requirements of Article 4 are not satisfied or where the requi site information and data have not been 
submitted within the prescribed period, th at such active substance shall not be 
included in Annex I of this Regulation. Th e decision shall specify the date on which 
the inclusion in Annex I becomes effective. 
2. By way of derogation from Articles 15(1) , 16(1) and 18(1) of this Regulation, and 
without prejudice to paragraphs 1 and 3 of th is Article, a Member State may continue 
to apply its current system or practice of  placing biocidal products on the market 
until two years after the date on which the in clusion in Annex I becomes effective. It 
may, in particular, according to its national rules, authorise the placing on the market in its territory of a biocid al product containing existing active substances which are 
evaluated under Regulation (EC) No. 1451/2007 on the second phase of the 10-year 
work programme referred to in Article 16(2)  of Directive 98/8/EC of the European 
Parliament and of the Council concerning the placing of biocidal products on the 
market
49 but which are not yet listed in Annex I to this Regulation for that product 
type. 
In derogation from the first subparagraph, in  the case of a decisi on not to include an 
active substance in Annex I of this Regul ation, a Member State may continue to 
apply its current system or practice of placing biocidal products on the market no 
longer than twelve months after the app licability date of a decision taken in 
accordance with the third s ubparagraph of paragraph 1. 
3. Following a decision to include a particul ar active substance in Annex I of this 
Regulation Member States shall ensure th at authorisations for biocidal products 
containing that active substance are granted, modified or cancelled as appropriate in 
accordance with this Regulat ion within two years from the date on which the 
inclusion becomes effective. 
To that effect, applications for authoris ation of biocidal products containing only 
existing active substances shall be subm itted to the competent authorities of the 
Member States no later than the date which the inclusion of the active substance(s) in Annex I of this Regulation becomes effec tive. In the case of biocidal products 
containing more than one active substance, applications for authorisation shall be 
submitted no later than the date on which th e inclusion of the last active substance 
becomes effective. 
Biocidal products, for which an applicati on for a product authorisation has not been 
submitted in accordance with the second s ubparagraph, shall no longer be placed on 
the market with effect from six months af ter the date on which the inclusion becomes 
effective. Disposal, storage and use of exis ting stocks of biocidal products for which 
                                                
 
49 OJ L 325, 11.12.2007, p. 3  
EN 85   EN an application for authorisation has not been submitted in accordance with the 
second subparagraph are allowed until eighteen months after the date on which the inclusion becomes effective. 
4. Biocidal products for which the compet ent authority of the Member State has 
rejected an application for authorisati on submitted under paragraph 3 or has decided 
not to grant authorisation, sh all no longer be placed on the market with effect from 
six months after such a rejection or a decision. 
Article 78 
Transitional measures concerning active substances evaluated under Directive 98/8/EC 
1. The Agency shall be responsible for coor dinating the evaluati on process of dossiers 
submitted after 1 January 2012 and shall facili tate the preparation of the evaluation 
by providing organisational a nd technical support to th e Member States and the 
Commission. 
2. Dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation 
has not been completed by 1 January 2013 sh all continue to be evaluated by the 
competent authorities in accordance with the provisions of Directive 98/8/EC and, 
where relevant, Regulation (EC) No 1451/2007.  
Notwithstanding paragraph 1, the Agency shal l also be responsible for coordinating 
the evaluation process of dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by 1 January 2013 and shall facilitate the preparation of the evalua tion by providing organisational and technical 
support to the Member States and the Commission from 1 January 2014. 
Article 79 
Transitional measures concerning low-risk biocidal products registered under Directive 
98/8/EC 
1. Low-risk biocidal products as defined in Article 2(1) (b) of Directive 98/8/EC shall 
be registered in accordance with point (i) of  Article 3(2) of Directive 98/8/EC. The 
provisions of Directive 98/8/EC shall apply to these products until the expiry of the 
registration. The registration shall not be renewable. 
2. Applications for the registra tion of low-risk biocidal produ cts as defined in point (b) 
of Article 2(1) of Directive 98/8/EC shall be submitted at the latest twelve months 
after the date on which the inclusi on in Annex IA becomes effective. 
Low-risk biocidal products as defined in point (b) of Article 2(1) of Directive 
98/8/EC for which an application was submitted in accordance with the first subparagraph may continue to be placed on th e market until the date of the decision 
granting the registration or refusing to grant the registration. In th e case of a refusal 
to grant a registration to place such low-ri sk biocidal product on the market, such 
low-risk biocidal product shall no longer be  placed on the market  within six months 
after such decision.  
EN 86   EN Low-risk biocidal products as defined in point (b) of Article 2(1) of Directive 
98/8/EC for which an application was not submitted in accordance with the first 
subparagraph may continue to be placed on th e market until six months after the date 
referred to in paragraph 1.  
Disposal, storage and use of existing stocks  of low-risk biocidal products which are 
not authorised for the relevant use by the competent authority are allowed until twelve months after the date of the decision referred to in the second s ubparagraph or 
twelve months after the date referred to in the third subparagraph, whichever is the 
later. 
3. This Regulation shall apply to low-risk bi ocidal products as defi ned in point (b) of 
Article 2(1) of Directive 98/8/ EC as of the exp iry of th e registration referred to in 
paragraph 1. 
Article 80 
Transitional measures concerning in situ generated active substances  
1. Applications for the authoris ation of substances, mixtures  and devices considered as 
biocidal products in accordance with the sec ond sentence of point (a) of Article 3(1) 
which were available on the market on ... [OJ:  insert the date referred to in the first 
subparagraph of Article 85] shall be s ubmitted at the latest by 1 January 2017. 
2. Substances, mixtures and devices considered  as biocidal products in accordance with 
the second sentence of point (a) of Article 3(1) which were available on the market 
on ... [OJ: insert the date referred to in the first subparagraph of  Article 85] and for 
which an application was submitted in accordance with paragraph 1 may continue to be placed on the market until the date of the decision granting the authorisation or refusing to grant the authorisa tion. In the case of a refusal to  grant an authorisation to 
place such biocidal product on the market, such biocidal product shall no longer be 
placed on the market within six months after such decision. 
Substances, mixtures and devi ces considered as biocidal products in accordance with 
the second sentence of point (a) of Article 3(1) which were available on the market 
on ... [OJ: insert the date referred to in  the first subparagraph of Article 85]  and for 
which an application was not submitte d in accordance with paragraph 1 may 
continue to be placed on the market until six months after the date referred to in paragraph 1.  
Disposal, storage and use of existing stoc ks of biocidal products which are not 
authorised for the relevant use by the competent authority or the Commission are 
allowed until twelve months after the date of the decision referred to in the first 
subparagraph or twelve months  after the date referred to in the second subparagraph, 
whichever is the later. 
Article 81 
Transitional measures concerning treated articles and materials 
By way of derogation from Article  47, treated articles and materi als that incorporate biocidal 
products which are not authorised in the Comm unity or in at least one Member State and  
EN 87   EN which were available on the market on ... [OJ: insert the date re ferred to in the first 
subparagraph of Article 85]  may, until the date of a decision granting authorisation to these 
biocidal products, continue to be placed on the market if the application for authorisation is 
submitted at the latest by 1 January 2017. In the cas e of a refusal to grant an authorisation to 
place a biocidal product on the market, treated ar ticles and materials that incorporate such 
biocidal product shall no longe r be placed on the market w ithin six months after such 
decision.  
Article 82 
Transitional measures concern ing food contact materials 
1. Applications for the aut horisation of biocidal produc ts which are food contact 
materials and which were available on the market on [OJ: insert the date referred to 
in the first subparagraph of Article 85]  shall be submitted at the latest 1 January 
2017. 
Food contact materials which were  available on the market on [OJ: insert the date 
referred to in the first subparagraph of Article 85]  for which an application was 
submitted in accordance with paragraph 1 ma y continue to be placed on the market 
until the date of the decisi on granting the authorisation or refusing to grant the 
authorisation. In case of a refusal to grant an authorisation to place such biocidal 
product on the market, such biocidal product shall no longer be placed on the market 
within six months after such decision. 
Food contact materials which were  available on the market on [OJ: insert the date 
referred to in the first  subparagraph of Article 85]  for which an application was not 
submitted in accordance with paragraph 1 ma y continue to be placed on the market 
until six months after the date referred to in paragraph 1.  
2. Disposal, storage and use of existing st ocks of biocidal products which are not 
authorised for the relevant use by the competent authority or the Commission is 
allowed until twelve months after the date  of the decision referred to in the second 
subparagraph of paragraph 1 or twelve months  after the date refe rred to in the third 
subparagraph of paragraph 1, whichever is the later. 
Article 83 
Transitional measures concerning a ccess to the active substance dossier 
As of 1 January 2014, the person responsible fo r the placing on the market of a biocidal 
product containing one or more ex isting active substances  shall own a dossier or have a letter 
of access to a dossier, or to each  component of the dossier, satis fying the requirements set out 
in Annex II for each of these active substances unless all relevant prot ection periods referred 
to in Article 49 have expired. 
Biocidal products for which the person res ponsible for the placing on the market does not 
fulfil the requirement of the first subparag raph shall no longer be placed on the market. 
Disposal, storage and use of existing stocks of biocidal products which do not fulfil the 
requirement of the first subparagraph is allowed until 1 January 2015.  
EN 88   EN Article 84 
Repeal 
Without prejudice to Article 78 and 79, Directive 98/8/EC is hereby repealed.  
References to the repealed Directive shall be construed as references  to this Regulation. 
Article 85 
Entry into force  
This Regulation shall enter into force on the 20th day following that of its publication in the 
Official Journal of the European Union . 
It shall apply from 1 January 2013. This Regulation shall be binding in  its entirety and directly applicable in all Member States. 
Done at Brussels,  
For the European Parliament For the Council 
The President The President   
EN 89   EN ANNEX I  
 
LIST OF ACTIVE SUBSTANCES WITH REQUIREMENTS FOR INCL USION IN BIOCIDAL PRODUCTS  
  
Common Name IUPAC Name 
Identification 
Numbers Minimum 
purity of the 
active 
substance in 
the biocidal 
product as 
placed on the 
market Date of 
inclusion Deadline for 
compliance with 
Article 77(3) 
(except for 
products containing 
more than one 
active substance, 
for which the 
deadline to comply 
with Article 77(3) 
shall be the one set 
out in the last of 
the inclusion 
decisions relating 
to its active 
substances) Expiry date of 
inclusion Product 
type Specific provisions (*) 
 
sulfuryl fluoride sulfuryl difluoride 
EC No: 220-281-5 
CAS No: 2699-79-8 994 g/kg 1 January 2009 31 December 2010 31 December 2018 8 Authorisa tions are subject to the following 
conditions: 
(1) the product may only be sold to and used 
by professionals trained to use it; 
(2) appropriate risk mitigation measures are 
included for operators and bystanders; 
(3) concentrations of sulfuryl fluoride in 
remote tropospheric air are monitored. 
Reports of the monitoring referred to in point (3)  
EN 90   EN are to be transmitted by authorisation holders 
directly to the Commission every fifth year starting 
from 1 January 2009. 
dichlofluanid N-
(Dichlorofluoromethyl
thio)-N′,N′-dimethyl-
N-phenylsulfamide 
EC No: 214-118-7 
CAS No: 1085-98-9  960 g/kg 1 March 2009 28 February 2011 28 February 2019 8 Authorisations are subject to the following 
conditions: 
(1) Products authorised for industrial and/or 
professional use must be used with 
appropriate personal protective equipment. 
(2) In view of the risks identified for the soil 
compartment appropri ate risk mitigation 
measures must be taken to protect that 
compartment. 
(3) Labels and/or safety-data sheets of 
products authorised for industrial use 
indicate that freshly treated timber must be stored after treatment on impermeable hard 
standing to prevent direct losses to soil and 
that any losses must be  collected for re-use 
or disposal.
 
clothianidin (E)-1-(2-Chloro-1,3-
thiazol-5-ylmethyl)-3-methyl-2-
nitroguanidine 
EC No: 433-460-1 CAS No: 210880-92-5 950 g/kg 1 February 
2010 31 January 2012 31 January 2020 8 Authorisations are subject to the following 
conditions: 
In view of the risk identified for the soil, surface 
water and groundwater co mpartments, products 
shall not be authorised for the treatment of wood that will be used outdoors unless data is submitted 
to demonstrate that the product will meet the 
requirements of Article 16 and Annex VI, if necessary by the applica tion of appropriate risk 
mitigation measures. In particular, labels and/or 
safety-data sheets of products authorised for industrial use indicate that  freshly treated timber 
shall be stored after treatment on impermeable hard  
EN 91   EN standing to prevent direct losses to soil and that any 
losses shall be collected for reuse or disposal. 
Difethialone 3-[3-(4 ′-
bromo[1,1 ′biphenyl]-
4-yl)-1,2,3,4-
tetrahydronaphth-1-yl]-4-hydroxy-2H-1-
benzothiopyran-2-one 
EC No: n/a CAS No: 104653-34-1 976 g/kg 1 November 
2009 31 October 2011 31 October 2014 14 In view of the fact that the active substance 
characteristics render it potentially persistent, liable 
to bioaccumulate and toxic, or very persistent and 
very liable to bioaccumulate, the active substance shall be considered a candidate for substitution in 
accordance with Article 9. 
Authorisations are subj ect to the following 
conditions: 
(1) The nominal concentration of the active 
substance in the products shall not exceed 0,0025 % w/w and on ly ready-for-use 
baits shall be authorised. 
(2) Products shall contain an aversive agent 
and, where appropriate, a dye. 
(3) Products shall not be used as tracking 
powder. 
(4) Primary as well as secondary exposure of 
humans, non-target animals and the 
environment are minimised, by considering and applying all appropriate 
and available risk mitigation measures. 
These include, amongst others, the restriction to professional use only, setting 
an upper limit to the package size and 
laying down obligations to use tamper resistant and secured bait boxes.
 
etofenprox 3-phenoxybenzyl-2-
(4-ethoxyphenyl)-2-970 g/kg 1 February 
2010 31 January 2012 31 January 2020 8 Authorisations are subject to the following 
conditions:  
EN 92   EN methylpropylether 
EC No: 407-980-2 
CAS No: 80844-07-1 In view of the risk identified for workers, products 
cannot be used year rou nd unless dermal absorption 
data is provided to dem onstrate that there are no 
unacceptable risks from chronic exposure. In 
addition, products intended for industrial use shall 
be used with appropriate personal protective equipment.
 
tebuconazole 1-(4-chlorophenyl)-
4,4-dimethyl-3-(1,2,4-triazol-1-
ylmethyl)pentan-3-ol 
EC No: 403-640-2 CAS No: 107534-96-3 950 g/kg 1 April 2010 31 March 2012 31 March 2020 8 Authorisations are subject to the following 
conditions: 
In view of the risks identified for the soil and 
aquatic compartments appropriate risk mitigation 
measures shall be taken to protect those compartments. In particular, labels and/or safety 
data sheets of products authorised for industrial use 
indicate that freshly treated  timber shall be stored 
after treatment under shelter or on impermeable 
hard standing to prevent direct losses to soil or 
water and that any losses shall be collected for reuse or disposal. 
In addition, products shall not be authorised for the 
in situ  treatment of wood outdoors or for wood that 
will be in continuous contact with water unless data 
is submitted to demonstrate that the product will meet the requirements of Article 16 and Annex VI, 
if necessary by the applica tion of appropriate risk 
mitigation measures. 
carbon dioxide carbon dioxide 
EC No: 204-696-9 
CAS No: 124-38-9 990 ml/l 1 November 
2009 31 October 2011 31 October 2019 14  
Îpropiconazole 1-[[2-(2,4- 930 g/kg 1 April 2010 31 March 2012 31 March 2020 8 Authorisations are subject to the following  
EN 93   EN dichlorophenyl)-4-
propyl-1,3-dioxolan-
2-yl]methyl]-1H-1,2,4-triazole 
EC No: 262-104-4 
CAS No: 60207-90-1 conditions: 
In view of the assumptions made during the risk 
assessment, products authorised for industrial and/or professional use shall be used with 
appropriate personal protective equipment, unless it 
can be demonstrated in th e application for product 
authorisation that risks to industrial and/or 
professional users can be reduced to an acceptable 
level by other means. 
In view of the risks identified for the soil and 
aquatic compartments appropriate risk mitigation 
measures shall be taken to protect those 
compartments. In particular, labels and/or safety 
data sheets of products authorised for industrial use shall indicate that freshly treated timber shall be 
stored after treatment under shelter or on 
impermeable hard standing to prevent direct losses to soil or water and that any losses shall be 
collected for reuse or disposal. 
In addition, products shall not be authorised for the 
in situ  treatment of wood outdoors or for wood that 
will be exposed to weathering unless data is 
submitted to demonstrate that the product will meet the requirements of Article 16 and Annex VI, if 
necessary by the applica tion of appropriate risk 
mitigation measures. 
Difenacoum 3-(3-biphenyl-4-yl-
1,2,3,4-tetrahydro-1-
naphthyl)-4-hydroxycoumarin 
EC No: 259-978-4 960 g/kg 1 April 2010 31 March 2012 31 March 2015 14 In view of the fact that the active substance 
characteristics render it potentially persistent, liable 
to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, the active substance 
shall be considered a candidate for substitution in 
accordance with Article 9. 
Authorisations are subj ect to the following  
EN 94   EN CAS No: 56073-07-5 conditions: 
(1) The nominal concentration of the active 
substance in the products shall not exceed 75 mg/kg and only ready-for-use products 
shall be authorised. 
(2) Products shall contain an aversive agent 
and, where appropriate, a dye. 
(3) Products shall not be used as tracking 
powder. 
(4) Primary as well as secondary exposure of 
humans, non-target animals and the 
environment are minimised, by considering and applying all appropriate 
and available risk mitigation measures. 
These include, amongst others, the restriction to professional use only, setting 
an upper limit to the package size and 
laying down obligations to use tamper 
resistant and secured bait boxes.
 
K-HDO Cyclohexylhydroxydi
azene 1-oxide, potassium salt 
EC No: n/a 
CAS No: 66603-10-9 (This entry also covers 
the hydrated forms of 
K-HDO) 977 g/kg 1 July 2010 30 June 2012 30 June 2020 8 Authorisations are subject to the following 
conditions: 
(1) in view of the po ssible risks for the 
environment and workers, products shall 
not be used in other systems than industrial, fully automated and closed ones 
unless the application for product 
authorisation demonstrates that risks can be reduced to acceptable levels in 
accordance with Article 16 and Annex VI; 
(2) in view of the assumptions made during 
the risk assessment, products shall be used  
EN 95   EN with appropriate personal protective 
equipment, unless the application for 
product authorisation demonstrates that risks to users can be reduced to acceptable 
levels by other means; 
(3) in view of the risk identified for infants, 
products shall not be used for the 
treatment of wood that may enter in direct 
contact with infants.  
IPBC 3-iodo-2-propynyl 
butylcarbamate 
EC No: 259-627-5 CAS No: 55406-53-6 980 g/kg 1 July 2010 30 June 2012 30 June 2020 8 Authorisations are subject to the following 
conditions: 
In view of the assumptions made during the risk 
assessment, products authorised for industrial 
and/or professional use, shall be used with 
appropriate personal protective equipment, unless it can be demonstrated in th e application for product 
authorisation that risks to industrial and/or 
professional users can be reduced to an acceptable level by other means. 
In view of the risks identified for the soil and 
aquatic compartments appropriate risk mitigation measures shall be taken to protect those 
compartments. In particular, labels and/or safety 
data sheets of products authorised for industrial use shall indicate that freshly treated timber shall be 
stored after treatment under shelter or on 
impermeable hard standing to prevent direct losses to soil or water and that any losses shall be 
collected for reuse or disposal. 
Thiabendazole 2-thiazol-4-yl-1H-
benzoimidazole 985 g/kg 1 July 2010 30 June 2012 30 June 2020 8 Authorisations are subject to the following 
conditions: 
In view of the assumptions made during the risk  
EN 96   EN EC No: 205-725-8 
CAS No: 148-79-8 assessment, products authorised for industrial 
and/or professional use, with respect to the double-
vacuum and dipping application tasks, shall be used with appropriate personal  protective equipment, 
unless it can be demonstrated in the application for 
product authorisation that risks to industrial and/or professional users can be reduced to an acceptable 
level by others means. 
In view of the risks identified for the soil and 
aquatic compartments appropriate risk mitigation 
measures shall be taken to protect those 
compartments. In particular, labels and/or safety 
data sheets of products authorised for industrial use 
shall indicate that freshly treated timber shall be stored after treatment under shelter or on 
impermeable hard standing to prevent direct losses 
to soil or water and that any losses shall be collected for reuse or disposal. 
Products shall not be authorised for the in situ 
treatment of wood outdoors or for wood that will be exposed to weathering, unless data is submitted to 
demonstrate that the product will meet the 
requirements of Article 16 and Annex VI, if necessary by the applica tion of appropriate risk 
mitigation measures. 
thiamethoxam thiamethoxam 
EC No: 428-650-4 
CAS No: 153719-23-4 980 g/kg 1 July 2010 30 June 2012 30 June 2020 8 Authorisations are subject to the following 
conditions: 
In view of the assumptions made during the risk 
assessment, products authorised for industrial and/or professional use shall be used with 
appropriate personal protective equipment, unless it 
can be demonstrated in th e application for product 
authorisation that risks to industrial and/or 
professional users can be reduced to an acceptable  
EN 97   EN level by other means. 
In view of the risks identified for the soil and 
aquatic compartments appropriate risk mitigation measures shall be taken to protect those 
compartments. In particular, labels and/or safety 
data sheets of products authorised for industrial use shall indicate that freshly treated timber shall be 
stored after treatment under shelter or on 
impermeable hard standing to prevent direct losses to soil or water and that any losses shall be 
collected for reuse or disposal. 
Products shall not be authorised for the in situ  
treatment of wood outdoors or for wood that will be 
exposed to weathering, unless data have been submitted to demonstrate that the product will meet 
the requirements of Article 16 and Annex VI, if 
necessary by the applica tion of appropriate risk 
mitigation measures. 
(*) For the implementation of the common principles of Annex VI, the content and conclusions of assessment reports are availabl e on the Commission website: 
http://ec.europa.eu/comm/environment/biocides/index.htm   
EN 98   EN ANNEX II  
Data requirements for active substances 
1. Dossiers on active substances shall contain the information needed to establish, 
where relevant, Acceptable Daily Intake ( ADI), Acceptable Oper ator Exposure Level 
(AOEL), Predicted Environmental Concen tration (PEC) and Predicted No-Effect 
Concentration (PNEC).  
2. Information which is however not necessary  owing to the nature of the biocidal 
product or of its proposed uses need not be supplied.  
3. A detailed and full description of the studies  conducted and of the methods used or a 
bibliographical reference to thos e methods shall be included.  
The formats made available by the Commissi on must be used for submission of the 
dossiers. In addition, the special software  package (IUCLID) made available by the 
Commission must be used for those parts of  the dossiers to which IUCLID applies. 
Formats and further guidance on data re quirements and dossier preparation are 
available on the Agency homepage. 
4. Tests submitted for the purpose of authorisat ion shall be conducted according to the 
methods described in Council Regulation (EC) No 440/200850. However, if a method 
is inappropriate or not described, other me thods shall be used which are, whenever 
possible, internationally r ecognised and must be justif ied in the application.  
5. Tests performed should comply with the relevant requirements of protection of 
laboratory animals, set out in Council Di rective 86/609/EEC on the approximation of 
laws, regulations and administrative provisi ons of the Member States regarding the 
protection of animals used for experi mental and other scientific purposes51, and, in 
the case of ecotoxicological and toxicologica l tests, good laboratory practice, set out 
in Directive 2004/10/EC of the European  Parliament and of the Council on the 
harmonisation of laws, regulations and admi nistrative provisions relating to the 
application of the principles  of good laboratory practice an d the verification of their 
application for tests on chemical substances52 or other international standards 
recognised as being equivalent by the Commission or the Agency. 
6. Where testing is done, a detailed descripti on (specification) of th e material used and 
its impurities must be provided. 
7. Where test data exist that have been generated before ... [OJ: insert the date referred 
to in the first subparagraph of Article 85]  by methods other than those laid down in 
Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new te sts according to the Regulation (EC) No 
440/2008 must be decided by the competent authority of the Member State concerned, on a case-by-case basis, taking into account , among other factors, the 
need to minimise testing on vertebrate animals. 
                                                
 
50 OJ L 142, 31.5.2008, p. 1. 
51 OJ L 358, 18.12.1986, p. 1.  
52 OJ L 50, 20.2.2004, p. 44.  
EN 99   EN 8. All available relevant knowledge and info rmation in literature should be provided.  
9. Any other relevant physicochemical, toxico logical and ecotoxicological information 
that is available sh all also be provided.  
EN 100   EN TITLE  1 – CHEMICAL SUBSTANCES  
TIER I 
Information required to support the inclusion of a substance in Annex I is listed in the table 
below. The standard data package consists of tie r I data. Tier II data may need to be submitted 
depending on the characteristics and intende d use of the active substance or on the 
conclusions of the assessment of the tier I data, in particular if a danger for health or the 
environment has been identified. 
The table also provides specific rules accordi ng to which the required information may be 
omitted, replaced by other information or adapted in another way. If the conditions are met to 
allow adaptations, the applicant shall clearly stat e this fact and the reasons for each adaptation 
under the appropriate head ings in the dossier. 
Conditions for not requiring a specific test that are set out in the appropr iate test methods in 
the Regulation (EC) No 440/2008 that are not  repeated in column 2, also apply. 
Before new tests are carried out to determine th e properties listed in this Annex, all available 
in vitro data, in vivo data, historical human data, data from valid (Q)SARs and data from 
structurally related substances (read-across approach) shall be assessed first. In vivo testing 
with corrosive substances at c oncentration/dose levels causing corrosivity shall be avoided. 
Prior to testing, further guidance on testing strategies should be consulted in addition to this 
Annex. 
  
Information required: Unless otherwise 
indicated, all data shall be provided at 
Tier I. 
 Specific rules for adaptation from standard 
information required: 
1. Applicant   
1.1. Name and address   
1.2. Active substance manufacturer 
(name, address, location of plant)   
2. Identity of the active substance   
2.1. Common name proposed or 
accepted by ISO and synonyms   
2.2. Chemical name (IUPAC 
nomenclature)   
2.3. Manufacturer's development code 
number(s)    
EN 101   EN 2.4. CAS and EC numbers (if available)   
2.5. Molecular and structural formula 
(including full details of any isomeric 
composition), molecular mass   
2.6. Method of manufacture (syntheses 
pathway in brief terms) of active substance   
2.7. Specification of purity of the active 
substance in g/kg or g/l, as appropriate   
2.8. Identity of impurities and additives 
(e.g. stabilisers), together with the 
structural formula and the possible 
range expressed as g/kg or g/l, as appropriate   
2.9. The origin of the natural active 
substance or the precursor(s) of the 
active substance, e.g. an extract of a flower   
2.10. Exposure data in conformity with 
Annex VIIA to Directive 92/32/EEC   
3. Physical and chemical properties 
of the active substance   
3.1. State of the substance at 20°C 
and 101,3 kPa    
3.2. Melting/freezing point  3.2. The study does not need to be conducted 
below a lower limit of -20°C. 
3.3. Boiling point  3.3. The study does not need to be 
conducted:  
– for gases; or 
– for solids which either melt above 300°C 
or decompose before boiling. In such cases 
the boiling point under reduced pressure may be estimated or measured; or 
– for substances which decompose before 
boiling (e.g. auto-oxidation, rearrangement, degradation, decomposition, etc.). 
3.4. Relative density  3.4. The study does not need to be conducted 
if: 
 – the substance is only stable in solution in a 
particular solvent and the solution density is 
similar to that of the solvent. In such cases, an indication of whether the solution density 
is higher or lower than the solvent density is 
sufficient; or  
EN 102   EN – the substance is a gas. In this case, an 
estimation based on calculation shall be 
made from its molecular weight and the 
Ideal Gas Laws. 
3.5. Vapour pressure  3.5. The study does not need to be conducted 
if the melting point is above 300°C. 
If the melting point is between 200°C and 
300°C, a limit value based on measurement or a recognised calculation method is 
sufficient. 
3.6. Surface tension  3.6. The study need only be conducted if:
 
– based on structure, surface activity is 
expected or can be predicted; or  
– surface activity is a desired property of the 
material. 
If the water solubility is below 1 mg/l at 
20°C the test does not need to be conducted.  
3.7. Water solubility   3.7. The study does not need to be conducted 
if: 
 – the substance is hydrolytically unstable at 
pH 4, 7 and 9 (half-life less than 12 hours); 
or – the substance is readily oxidisable in water.
 
If the substance appears "insoluble" in water, a limit test up to the detection limit of the 
analytical method shall be performed. 
3.8. Partition coefficient n-octanol/water  3.8. The study does not need to be conducted 
if the substance is inorganic. If the test 
cannot be performed (e.g. the substance 
decomposes, has a high surface activity, reacts violently during the performance of 
the test or does not dissolve in water or in 
octanol, or it is not possible to obtain a sufficiently pure substance), a calculated 
value for log P as well as details of the 
calculation method shall be provided. 
3.9. Flash-point  3.9. The study does not need to be conducted 
if: 
 
– the substance is inorganic; or 
– the substance only contains volatile 
organic components with flash-points above 
100°C for aqueous solutions; or 
– the estimated flash-point is above 200°C; 
or  
EN 103   EN – the flash-point can be accurately predicted 
by interpolation from existing characterised 
materials. 
3.10. Flammability  3.10. The study does not need to be 
conducted:  
– if the substance is a solid which possesses 
explosive or pyrophoric properties. These properties should always be considered 
before considering flammability; or 
– for gases, if the concentration of the 
flammable gas in a mixture with inert gases 
is so low that, when mixed with air, the concentration is all time below the lower 
limit; or 
– for substances which spontaneously ignite 
when in contact with air. 
3.11. Explosive properties  3.11. The study does not need to be 
conducted if: 
– there are no chemical groups associated 
with explosive properties present in the 
molecule; or 
– the substance contains chemical groups 
associated with expl osive properties which 
include oxygen and the calculated oxygen 
balance is less than –200; or 
– the organic substance or a homogenous 
mixture of organic substances contains 
chemical groups associated with explosive properties, but the exothermic decomposition 
energy is less than 500 J/g and the onset of 
exothermic decomposition is below 500 ºC; 
or 
- for mixtures of inorganic oxidising 
substances (UN Division 5.1) with organic 
materials, the concentration of the inorganic 
oxidising substance is: 
– less than 15 %, by mass, if assigned to UN 
Packaging Group I (high hazard) or II 
(medium hazard) 
– less than 30 %, by mass, if assigned to UN 
Packaging Group III (low hazard). 
Note: Neither a test for propagation of 
detonation nor a test for sensitivity to 
detonative shock is required if the 
exothermic decomposition energy of organic materials is less than 800 J/g.  
EN 104   EN 3.12. Self-ignition temperature  3.12. The study does not need to be 
conducted: 
 
– if the substance is explosive or ignites spontaneously with air at room temperature; 
or 
– for liquids non flammable in air, e.g. no 
flash point up to 200°C; or 
– for gases having no flammable range; or 
– for solids, if the substance has a melting 
point < 160°C, or if preliminary results 
exclude self-heating of the substance up to 400°C. 
3.13. Oxidising properties  3.13. The study does not need to be 
conducted if: 
– the substance is explosive; or – the substance is highly flammable; or 
– the substance is an organic peroxide; or 
– the substance is incapable of reacting 
exothermically with combustible materials, 
for example on the basis of the chemical 
structure (e.g. organic substances not containing oxygen or halogen atoms and 
these elements are not chemically bonded to 
nitrogen or oxygen, or inorganic substances not containing oxygen or halogen atoms). 
The full test does not need to be conducted 
for solids if the preliminary test clearly indicates that the test substance has oxidising 
properties. 
Note that as there is no test method to 
determine the oxidising properties of 
gaseous mixtures, the evaluation of these properties must be realised by an estimation 
method based on the comparison of the 
oxidising potential of gases in a mixture with that of the oxidising potential of oxygen in 
air. 
3.14. Granulometry  3.14. The study does not need to be 
conducted if the substa nce is marketed or 
used in a non solid or granular form. 
3.15. Stability in organic solvents and 
identity of relevant degradation products 
 Tier II 3.15. Stability in organic solvents and 
identity of relevant degradation products
 Only required if stability of the substance is 
considered to be critical.  
EN 105   EN 3.16. Dissociation constant Tier II 3.16. Dissociation constant 
3.17. Viscosity Tier II 3.17. Viscosity 
3.18. Solubility in organic solvents, 
including effect of temperature on 
solubility53 Tier II  
3.19. Stability in organic solvents 
used in biocidal products and identity 
of relevant breakdown products54  Tier II  
4. Methods of detection and 
identification   
4.1. Analytical methods for the 
determination of pure active substance 
and, where appropriate, for relevant 
degradation products, isomers and impurities of the active substance and 
additives (e.g. stabilisers)   
4.2. Analytical methods including 
recovery rates and the limits of determination for the active substance, 
and for residues thereof   
4.3 Analytical methods including 
recovery rates and the limits of 
determination for the active substance, and for residues thereof, 
in/on food or feedingstuffs and other 
products where relevant Tier II  
5. Effectiveness against target 
organisms and intended uses   
5.1. Function, e.g. fungicide, 
rodenticide, insecticide, bactericide   
5.2. Organism(s) to be controlled and 
products, organisms or objects to be 
protected   
5.3. Effects on target organisms, and 
likely concentration at which the active 
substance will be used   
5.4. Mode of action (including time 
delay)   
5.5. Field of use envisaged   
5.6. User: industrial, professional, 
general public (non-professional)   
                                                 
53 These data must be submitted for the purifi ed active substance of stated specification. 
54 These data must be submitted for the active substance of st ated specification.  
EN 106   EN 5.7. Information on the occurrence or 
possible occurrence of the development 
of resistance and appropriate 
management strategies   
5.8. Likely tonnage to be placed on the 
market per year   
6. Toxicological profile for man 
and animals including metabolism   
6.1. Skin irritation or skin corrosion 
 
  6.1. The assessment of this endpoint shall 
comprise the followi ng consecutive steps:
 
(1) an assessment of the available human and animal data,
(2) an assessment of the acid or alkaline 
reserve, (3) in vitro study for skin corrosion,
(4) in vitro study for skin irritation. 
Steps 3 and 4 do not need to be conducted if:
 
– the available informat ion indicates that the 
criteria are met for classification as corrosive to the skin or irritating to eyes; or 
– the substance is flammable in air at room 
temperature; or 
– the substance is classified as very toxic in 
contact with skin; or 
– an acute toxicity study by the dermal route 
does not indicate skin irritation up to the 
limit dose level (2 000 mg/kg body weight). 
6.1.1. In vivo skin irritation   6.1.1. The study does not need to be 
conducted if: 
– the substance is classified as corrosive to 
the skin or as a skin irritant; or 
– the substance is a strong acid (pH < 2,0) or 
base (pH > 11,5); or 
– the substance is flammable in air at room 
temperature; or 
– the substance is classified as very toxic in 
contact with skin; or 
– an acute toxicity study by the dermal route 
does not indicate skin irritation up to the 
limit dose level (2 000 mg/kg body weight). 
6.2. Eye irritation  6.2. The assessment of this endpoint shall 
comprise the followi ng consecutive steps:
  
EN 107   EN (1) an assessment of the available human and 
animal data, 
(2) an assessment of the acid or alkaline 
reserve, 
(3) in vitro study for eye irritation. 
Step 3 does not need to be conducted if: 
– the available informat ion indicates that the 
criteria are met for classification as corrosive 
to the skin or irritating to eyes; or 
– the substance is flammable in air at room 
temperature. 
6.2.1. In vivo eye irritation   6.2.1. The study does not need to be 
conducted if: 
– the substance is classified as irritating to 
eyes with risk of serious damage to eyes; or
– the substance is classified as corrosive to the skin and provided that the applicant 
classified the substance as eye irritant; or 
– the substance is a strong acid (pH < 2,0) or 
base (pH > 11,5); or 
– the substance is flammable in air at room 
temperature. 
6.3. Skin sensitisation  6.3. The assessment of this endpoint shall 
comprise the followi ng consecutive steps:
 
(1) an assessment of the available human, animal and alternative data, 
(2) In vivo testing. 
Step 2 does not need to be conducted if: – the available informat ion indicates that the 
substance should be classified for skin 
sensitisation or corrosivity; or 
– the substance is a strong acid (pH < 2,0) or 
base (pH > 11,5); or 
– the substance is flammable in air at room 
temperature. 
The Murine Local Lymph Node Assay 
(LLNA) is the first-choice method for in 
vivo testing. Only in exceptional 
circumstances should another test be used. Justification for the use of another test shall 
be provided.  
EN 108   EN 6.4. Mutagenicity  6.4. Appropriate in vivo mutagenicity studies 
shall be considered in case of a positive 
result in any of the genotoxicity studies in 
Tier I. 
6.4.1. In vitro gene mutation study in bacteria  6.4.1. Further mutagenicity studies shall be 
considered in case of a positive result. 
6.4.2. In vitro cytogenicity study in 
mammalian cells or in vitro 
micronucleus study  6.4.2. The study does not usually need to be 
conducted if: 
– adequate data from an in vivo cytogenicity 
test are available or 
– the substance is known to be carcinogenic 
category 1A or 1B or mutagenic category 
1A, 1B or 2. 
6.4.3. In vitro gene mutation study in 
mammalian cells, if a negative result in Tier I, sections 6.4.1. and section 6.4.2.  6.4.3. The study does not usually need to be 
conducted if adequate data from a reliable in vivo mammalian gene mutation test are 
available. 
6.4.4. In vivo genotoxicity study Tier II 6.4.4 If there is a positive result in any of the 
in vitro genotoxicity studies in Tier I and there are no results available from an in vivo 
study already, an appropriate in vivo somatic 
cell genotoxicity study shall be proposed by the applicant. 
If there is a positive result from an in vivo 
somatic cell study available, the potential for germ cell mutagenicity should be considered 
on the basis of all available data, including 
toxicokinetic evidence. If no clear conclusions about germ cell mutagenicity 
can be made, additional investigations shall 
be considered. 
6.5. Acute toxicity  6.5. The study/ies do(es) not generally need 
to be conducted if: 
– the substance is classified as corrosive to 
the skin. 
In addition to the oral route (6.5.1), for 
substances other than gases, the information mentioned under 6.5.2 to 6.5.3 shall be 
provided for at least one other route. The 
choice for the second route will depend on the nature of the substance and the likely 
route of human exposure. If there is only one 
route of exposure, information for only that route need be provided. 
6.5.1. By oral route  6.5.1. The study need not be conducted if a 
study on acute toxicity by the inhalation 
route (6.5.2) is available.  
EN 109   EN 6.5.2. By inhalation  6.5.2. Testing by the inhalation route is 
appropriate if exposure of humans via 
inhalation is likely taking into account the 
vapour pressure of the substance and/or the possibility of exposure to aerosols, particles 
or droplets of an inhalable size. 
6.5.3. By dermal route  6.5.3. Testing by the dermal route is 
appropriate if: 
 
(1) inhalation of the substance is unlikely; 
and 
(2) skin contact in production and/or use is 
likely; and 
(3) the physicochemical and toxicological 
properties suggest potential for a significant 
rate of absorption through the skin. 
6.6. Repeated dose toxicity    
6.6.1. Short-term repeated dose toxicity study (28 days), one species, male and 
female, most appropriate route of 
administration, having regard to the likely route of human exposure.  6.6.1. The short-term toxicity study 
(28 days) does not need to be conducted if: 
– a reliable sub-chronic (90 days) or chronic 
toxicity study is available, provided that an appropriate species, dosage, solvent and 
route of administration were used; or 
– where a substance undergoes immediate 
disintegration and there are sufficient data on 
the cleavage products; or 
– relevant human exposure can be excluded 
in accordance with Annex IV section 3 
The appropriate route shall be chosen on the 
following basis: 
Testing by the dermal route is appropriate if: 
(1) inhalation of the substance is unlikely; 
and 
(2) skin contact in production and/or use is 
likely; and 
(3) the physicochemical and toxicological 
properties suggest potential for a significant 
rate of absorption through the skin. 
Testing by the inhalation route is appropriate 
if exposure of humans via inhalation is likely 
taking into account the vapour pressure of the substance and/or the possibility of 
exposure to aerosols, particles or droplets of  
EN 110   EN an inhalable size. 
The sub-chronic toxicity study (90 days) 
(Tier II, section 6.6.2) shall be proposed by 
the applicant if: the frequency and duration of human exposure indicates that a longer 
term study is appropriate;  
and one of the following conditions is met: – other available data indicate that the 
substance may have a dangerous property 
that cannot be detected in a short-term 
toxicity study; or 
– appropriately designed toxicokinetic 
studies reveal accumulation of the substance 
or its metabolites in certain tissues or organs 
which would possibly remain undetected in a short term toxicity study but which are liable 
to result in adverse effects after prolonged 
exposure. 
Further studies shall be proposed by the 
applicant or may be required in case of: 
– failure to identify a NOAEL in the 28 or 
the 90 days study, unless the reason for the 
failure to identify a NOAEL is absence of 
adverse toxic effects; or 
– toxicity of particular concern (e.g. 
serious/severe effects); or 
– indications of an effect for which the 
available evidence is inadequate for 
toxicological and/or risk characterisation. In 
such cases it may also be more appropriate to 
perform specific toxicological studies that 
are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or 
– the route of exposure used in the initial 
repeated dose study was inappropriate in relation to the expected route of human 
exposure and route-to-route extrapolation 
cannot be made; or 
– particular concern regarding exposure (e.g. 
use in consumer products leading to 
exposure levels which are close to the dose levels at which toxicity to humans may be 
expected); or 
– effects shown in substances with a clear 
relationship in molecular structure with the 
substance being studied, were not detected in 
the 28 or the 90 days study.  
EN 111   EN 6.6.2. Sub-chronic toxicity study (90-
day), one species, rodent, male and 
female, most appropriate route of 
administration, having regard to the likely route of human exposure. Tier II 6.6.2. The sub-chronic toxicity study 
(90 days) does not need to be conducted if: 
– a reliable short-term toxicity study 
(28 days) is available showing severe toxicity effects according to the criteria for 
classifying the substance as R48, for which 
the observed NOAEL-28 days, with the application of an appropriate uncertainty 
factor, allows the extrapolation towards the 
NOAEL-90 days for the same route of 
exposure; or 
– a reliable chronic toxicity study is 
available, provided that an appropriate 
species and route of administration were 
used; or 
– a substance undergoes immediate 
disintegration and there are sufficient data on 
the cleavage products (both for systemic 
effects and effects at the site of uptake); or 
– the substance is unreactive, insoluble and 
not inhalable and there is no evidence of absorption and no eviden ce of toxicity in a 
28-day "limit test", particularly if such a 
pattern is coupled with limited human exposure. 
The appropriate route shall be chosen on the 
following basis: 
Testing by the dermal route is appropriate if: 
(1) skin contact in production and/or use is 
likely; and 
(2) the physicochemical properties suggest a 
significant rate of absorption through the skin; and 
(3) one of the following conditions is met: 
– toxicity is observed in the acute dermal 
toxicity test at lower doses than in the oral 
toxicity test; or 
– systemic effects or other evidence of 
absorption is observed in skin and/or eye 
irritation studies; or 
– in vitro tests indicate significant dermal 
absorption; or 
– significant dermal toxicity or dermal 
penetration is recognised for structurally related substances.  
EN 112   EN Testing by the inhalation route is appropriate 
if: 
– exposure of humans via inhalation is likely 
taking into account the vapour pressure of the substance and/or the possibility of 
exposure to aerosols, particles or droplets of 
an inhalable size. 
Further studies shall be proposed by the 
applicant or may be required in case of: 
– failure to identify a NOAEL in the 90 days 
study unless the reason for the failure to 
identify a NOAEL is absence of adverse toxic effects; or 
– toxicity of particular concern (e.g. 
serious/severe effects); or 
– indications of an effect for which the 
available evidence is inadequate for 
toxicological and/or risk characterisation. In such cases it may also be more appropriate to 
perform specific toxicological studies that 
are designed to investigate these effects (e.g. immunotoxicity, neurotoxicity); or 
– particular concern regarding exposure (e.g. 
use in consumer products leading to exposure levels which are close to the dose 
levels at which toxicity to humans may be 
expected).  
6.6.3. Long-term repeated toxicity study (≥ 12 months) Tier II 6.6.3. A long-term repeated toxicity study 
(≥ 12 months) may be proposed by the 
applicant or required if the frequency and 
duration of human exposu re indicates that a 
longer term study is appropriate and one of 
the following conditions is met: 
– serious or severe toxicity effects of 
particular concern were observed in the 28-day or 90-day study for which the available 
evidence is inadequate for toxicological 
evaluation or risk characterisation; or 
– effects shown in substances with a clear 
relationship in molecular structure with the 
substance being studied were not detected in the 28-day or 90-day study; or 
– the substance may have a dangerous 
property that cannot be detected in a 90-day study. 
6.6.4. Further studies Tier II 6.6.4. Further studies shall be proposed by 
the applicant or may be required in case of:
  
EN 113   EN – toxicity of particular concern (e.g. 
serious/severe effects); or
– indications of an effect for which the 
available evidence is inadequate for toxicological evaluation and/or risk 
characterisation. In such  cases it may also be 
more appropriate to perform specific toxicological studies that are designed to 
investigate these effects (e.g. 
immunotoxicity, neurotoxicity); or 
– particular concern regarding exposure (e.g. 
use in consumer products leading to exposure levels which are close to the dose 
levels at which toxicity is observed). 
If a substance is known to have an adverse 
effect on fertility, meeting the criteria for 
classification as Repr Cat 1A or 1B: May 
damage fertility (H360F), and the available data are adequate to support a robust risk 
assessment, then no further testing for 
fertility will be necessary. However, testing for development toxicity must be considered. 
6.7. Reproductive toxicity  Tier II 6.7. The studies need not be conducted if:
 
– the substance is known to be a genotoxic carcinogen and appropriate risk management 
measures are implemented; or
– the substance is known to be a germ cell mutagen and appropriate risk management 
measures are implemented; or 
– the substance is of low toxicological 
activity (no evidence of toxicity seen in any 
of the tests available), it can be proven from toxicokinetic data that no systemic 
absorption occurs via relevant routes of 
exposure (e.g. plasma/blood concentrations below detection limit using a sensitive 
method and absence of the substance and of 
metabolites of the substance in urine, bile or exhaled air) and there is no or no significant 
human exposure. 
If a substance is known to have an adverse 
effect on fertility, meeting the criteria for 
classification as Repr Cat 1A or 1B: May 
damage fertility (H360F), and the available data are adequate to support a robust risk 
assessment, then no further testing for 
fertility will be necessary. However, testing for development toxicity must be considered. 
If a substance is known to cause 
developmental toxicity, meeting the criteria 
for classification as Repr Cat 1A or 1B: May 
damage the unborn child (H360D), and the available data are ad equate to support a  
EN 114   EN robust risk assessment, then no further 
testing for developmental toxicity will be 
necessary. However, testing for effects on 
fertility must be considered. 
6.7.1. Screening for reproductive/developmental toxicity, 
one species (OECD 421 or 422), if there 
is no evidence  from available 
information on structurally related 
substances, from (Q)SAR estimates or 
from in vitro methods that the substance 
may be a developmental toxicant.  6.7.1. This study does not need to be 
conducted if: 
– the substance is known to be a genotoxic 
carcinogen and appropriate risk management measures are implemented; or 
– the substance is known to be a germ cell 
mutagen and appropriate risk management 
measures are implemented; or 
– relevant human exposure can be excluded 
in accordance with Anne x IV section 3; or 
– a pre-natal developmental toxicity study 
(Tier II, 6.7.2) or a two-generation reproductive toxicity study (Tier II, section 
6.7.3) is available.  
If a substance is known to have an adverse 
effect on fertility, meeting the criteria for 
classification as Repr Cat 1A or 1B: May 
damage fertility (H360F), and the available data are adequate to support a robust risk 
assessment, then no further testing for 
fertility will be necessary. However, testing for development toxicity must be considered. 
If a substance is known to cause 
developmental toxicity, meeting the criteria for classification as Repr Cat 1A or 1B: May 
damage the unborn child (H360D), and the 
available data are ad equate to support a 
robust risk assessment, then no further 
testing for developmental toxicity will be necessary. However, testing for effects on 
fertility must be considered. 
In cases where there are serious concerns 
about the potential for adverse effects on 
fertility or development, either a pre-natal 
developmental toxicity study (Tier II, section 6.7.2) or a two generation reproductive 
toxicity study (Tier II, section 6.7.3) may be 
proposed by the applicant instead of the screening study. 
6.7.2. Pre-natal developmental toxicity 
study, one species, most appropriate 
route of administration, having regard to the likely route of human exposure 
(B.31 of the Regulation (EC) No 
440/2008 or OECD 414). Tier II 6.7.2. The study shall be initially performed 
on one species. A decision on the need to 
perform a study at this tonnage level or the next on a second species should be based on 
the outcome of the first test and all other 
relevant available data.  
EN 115   EN 6.7.3. Two-generation reproductive 
toxicity study, one species, male and 
female, most appropriate route of 
administration, having regard to the likely route of human exposure, unless 
already provided as part of Tier I 
requirements Tier II 6.7.3. The study shall be initially performed 
on one species. A decision on the need to 
perform a study at this tonnage level or the 
next on a second species should be based on the outcome of the first test and all other 
relevant available date. 
6.8. Toxicokinetics    
6.8.1. Dermal absorption study    
6.9. Carcinogenicity study Tier II 6.9. A carcinogenicity study may be 
proposed by the applicant or may be required 
if: 
– the substance has a widespread dispersive 
use or there is evidence of frequent or long-
term human exposure; and 
– the substance is classified as mutagen 
category 2 or there is  evidence from the 
repeated dose study(ies) that the substance is able to induce hyperplasia and/or pre-
neoplastic lesions. 
If the substance is classified as mutagen 
category 1A or 1B, the default presumption 
would be that a genotoxic mechanism for 
carcinogenicity is likely. In these cases, a carcinogenicity test will normally not be 
required.  
6.9.1. Medical surveillance data on manufacturing plant personnel if 
available   
6.9.2. Direct observa tion, e.g. clinical 
cases, poisoning incidents if available   
6.9.3. Health records, both from 
industry and any other available 
sources   
6.9.4. Epidemiological studies on the 
general population, if available   
6.9.5. Diagnosis of poisoning 
including specific signs of poisoning 
and clinical tests, if available   
6.9.6. Sensitisation/allergenicity 
observations, if available   
6.9.7. Specific treatment in case of an 
accident or poisoning: first aid 
measures, antidotes and medical 
treatment, if known   
6.9.8. Prognosis following poisoning    
EN 116   EN 6.10. Summary of mammalian 
toxicology and conclusions, including 
no observed adverse effect level 
(NOAEL), no observed effect level 
(NOEL), overall evaluation with regard to all toxicological data and 
any other information concerning the 
active substances. Where possible any suggested worker protection 
measures should be included in 
summary form   
6.11 Additional studies Tier II Additional data which may be required 
depending on the characteristics and intended use of the active substance. 
6.11.1 Neurotoxicity study Tier II If the active substance is an 
organophosphorus compound or if there are 
any other indications that the active substance may have neurotoxic properties 
then neurotoxicity studies will be required. 
The test species is the adult hen unless another test species is justified to be more 
appropriate. If appropriate, delayed 
neurotoxicity tests will be required. If anticholine esterase activity is detected a test 
for response to reactivating agents should be 
considered 
6.11.2. Toxic effects on livestock and 
pets Tier II  
6.11.3. Studies related to the 
exposure of the active substance to humans Tier II  
6.11.4. Food and feedingstuffs 
 Tier II If the active substance is to be used in 
mixtures for use where food for human 
consumption is prepared, consumed or 
stored, or where feedingstuff for livestock 
is prepared, consumed or stored the tests referred to in Section 9.1 shall be required 
6.11.5. If any other tests related to the 
exposure of the active substance to 
humans, in its proposed biocidal 
products, are considered necessary, 
then the test(s) referred to in Section 9.1, Title I of Annex III shall be 
required Tier II  
6.11.6. If the active substance is to be 
used in products for action against 
plants then tests to assess toxic 
effects of metabolites from treated 
plants, if any, where different from those identified in animals shall be 
required Tier II  
6.11.7. Mechanistic study - any 
studies necessary to clarify effects Tier II   
EN 117   EN reported in toxicity studies 
7. Ecotoxicological profile 
including environmental fate and 
behaviour    
7.1. Aquatic toxicity   7.1. Long-term toxicity testing shall be 
proposed by the applicant if the assessment performed under Tier I indicates the need to 
investigate further the effects on aquatic 
organisms. The choice of the appropriate 
test(s) depends on the results of the 
assessment performed under Tier I. 
7.1.1. Short-term toxicity testing on 
invertebrates (preferred species Daphnia)  
 
The applicant may consider long-term toxicity testing instead of short-term.  7.1.1. The study does not need to be 
conducted if: 
– there are mitigating factors indicating that 
aquatic toxicity is unlikely to occur, for 
instance if the substance is highly insoluble in water or the substance is unlikely to cross 
biological membranes; or 
– a long-term aquatic toxicity study on 
invertebrates is available; or 
– adequate information for environmental 
classification and labelling is available. 
The long-term aquatic toxicity study on 
Daphnia (Tier II, section 7.1.5) shall be considered if the substance is poorly water 
soluble. 
7.1.2. Growth inhibition study aquatic 
plants (algae preferred)  7.1.2. The study does not need to be 
conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to 
occur for instance if the substance is highly 
insoluble in water or the substance is unlikely to cross biological membranes. 
7.1.3. Short-term toxicity testing on fish: 
The applicant may consider long-term 
toxicity testing instead of short-term.   7.1.3. The study does not need to be 
conducted if: 
– there are mitigating factors indicating that 
aquatic toxicity is unlikely to occur, for 
instance if the substance is highly insoluble 
in water or the substance is unlikely to cross biological membranes; or 
– a long-term aquatic toxicity study on fish is 
available. 
7.1.4. Activated sludge respiration 
inhibition testing  7.1.4. The study does not need to be 
conducted if: 
– there is no emission to a sewage treatment 
plant; or 
– there are mitigating factors indicating that  
EN 118   EN microbial toxicity is unlikely to occur, for 
instance the substance is highly insoluble in 
water; or 
– the substance is found to be readily 
biodegradable and the applied test 
concentrations are in the range of 
concentrations that can be expected in the influent of a sewage treatment plant. 
The study may be replaced by a nitrification 
inhibition test if available data show that the 
substance is likely to be an inhibitor of 
microbial growth or function, in particular nitrifying bacteria. 
7.1.5. Long-term toxicity testing on 
invertebrates (preferred species 
Daphnia), (unless already provided as part of Tier I requirements) Tier II   
7.1.6. Long-term toxicity testing on fish, 
(unless already provided as part of Tier I 
requirements) 
 
The information shall be provided for 
one of the sections 7.1.6.1, 7.1.6.2 or 7.1.6.3. Tier II   
7.1.6.1. Fish early -life stage (FELS) 
toxicity test Tier II   
7.1.6.2. Fish short-term toxicity test on 
embryo and sac-fry stages Tier II   
7.1.6.3. Fish, juvenile growth test Tier II   
7.2. Degradation  7.2. Further biotic degradation testing shall 
be considered if the assessment performed 
under Tier I indicates the need to investigate further the degradation of the substance and 
its degradation products. The choice of the 
appropriate test(s) depends on the results of the assessment performed under Tier I and 
may include simulation testing in appropriate 
media (e.g. water, sediment or soil). 
7.2.1. Biotic    
7.2.1.1. Ready biodegradability  7.2.1.1. The study does not need to be 
conducted if the substance is inorganic. 
7.2.1.2. Simulation testing on ultimate 
degradation in surface water Tier II 7.2.1.2. The study need not be conducted if:
 
– the substances is highly insoluble in water; or 
– the substance is readily biodegradable.  
EN 119   EN 7.2.1.3. Soil simulation testing (for 
substances with a high potential for 
adsorption to soil) Tier II 7.2.1.3. The study need not be conducted:
 
– if the substance is readily biodegradable; 
or 
– if direct and indirect exposure of soil is 
unlikely. 
7.2.1.4. Sediment simulation testing (for 
substances with a high potential for adsorption to sediment) Tier II 7.2.1.4. The study need not be conducted:
 – if the substance is readily biodegradable; 
or 
– if direct and indirect exposure of sediment 
is unlikely. 
7.2.2. Abiotic    
7.2.2.1. Hydrolysis as a function of pH.  7.2.2.1. The study does not need to be 
conducted if: 
– the substance is readily biodegradable; or
– the substance is highly insoluble in water. 
7.2.3. Identification of degradation 
products Tier II 7.2.3. Unless the substance is readily 
biodegradable 
7.3. Fate and behaviour in the environment    
7.3.1. Adsorption/desorption screening  7.3.1. The study does not need to be 
conducted if: 
– based on the physicochemical properties 
the substance can be expected to have a low 
potential for adsorption (e.g. the substance 
has a low octanol water partition coefficient); or 
– the substance and its relevant degradation 
products decompose rapidly.  
7.3.2. Bioaccumulation in aquatic 
species, preferably fish  Tier II 7.3.2. The study need not be conducted if: 
– the substance has a low potential for 
bioaccumulation (for instance a log Kow < 3) and/or a low potential to cross 
biological membranes; or 
– direct and indirect exposure of the aquatic 
compartment is unlikely. 
7.3.3. Additional information on 
adsorption/desorption depending on the 
results of the study required under Tier I Tier II 7.3.3. The study need not be conducted if:
 
– the substance has a low potential for bioaccumulation (for instance a log 
Kow < 3) and/or a low potential to cross 
biological membranes; or  
EN 120   EN – based on the physicochemical properties 
the substance can be expected to have a low 
potential for adsorption (e.g. the substance 
has a low octanol water partition coefficient); or 
– the substance and its degradation products 
decompose rapidly. 
7.4. Additional studies Tier II  
7.4.1. Acute toxicity test on one other, non-aquatic, non-target organism Tier II  
7.4.2. Any other biodegradability tests 
that are relevant from the results in section 7.2.1.1 Tier II  
7.4.3. Phototransformation in air 
(estimation method), including 
identification of breakdown products Tier II  
7.4.4. If the results from section 7.4.2 
indicate the need to do so, or the active 
substance has an overall low or absent 
abiotic degradation, then the tests described in sections 10.1.1 and 10.2.1 
and, where appropriate, section 10.3 
shall be required Tier II  
8. Measures necessary to protect man, 
animals and the environment Tier II Additional data which may be required 
depending on the characteristics and 
intended use of the active substance. 
8.1. Identification of any substances 
falling within the scope of List I or List II of the Annex to Directive 80/68/EEC 
on the protection of groundwater against 
pollution caused by certain dangerous 
substances55. 
Notes: 
(1) These data must be submitted for the 
purified active substance of stated 
specification. 
(2) These data must be submitted for the 
active substance of stated specification. Tier II  
9. Additional human health-related 
studies Tier II Additional data which may be required 
depending on the characteristics and 
intended use of the active substance. 
9.1. Food and feedingstuffs studies Tier II  
                                                 
55 OJ L 20, 26.1.1980, p. 43.  
EN 121   EN 9.1.1. Identification of degradation and 
reaction products and of metabolites of 
the active substan ce in treated or 
contaminated foods or feedingstuffs Tier II  
9.1.2. Behaviour of the residue of the 
active substance, its degradation 
products and, where relevant, its metabolites on the treated or 
contaminated food or feedingstuffs 
including the kinetics of disappearance Tier II  
9.1.3. Overall material balance for the 
active substance. Sufficient residue data 
from supervised trials to demonstrate that residues likely to arise from the 
proposed use would not be of concern 
for human or animal health Tier II  
9.1.4. Estimation of potential or actual 
exposure of the active substance to 
humans through diet and other means Tier II  
9.1.5. If residues of the active substance 
remain on feedingstuffs for a significant period of time then feeding and 
metabolism studies in livestock shall be 
required to permit evaluation of residues in food of animal origin Tier II  
9.1.6. Effects of industrial processing 
and/or domestic preparation on the 
nature and magnitude of residues of the active substance Tier II  
9.1.7. Proposed acceptable residues and 
the justification of their acceptability Tier II  
9.1.8. Any other available information 
that is relevant Tier II  
9.1.9. Summary and evaluation of data 
submitted under 1.1 to 1.8 Tier II  
9.2. Other test(s) related to the exposure 
to humans 
Suitable test(s) and a reasoned case will 
be required Tier II  
10. Additional studies on fate and 
behaviour in the environment Tier II 10. If the results of the ecotoxicological 
studies and the intended use(s) of the active substance indicate a danger for the 
environment then the tests described in this 
Section shall be conducted. 
10. Fate and behaviour in soil Tier II   
EN 122   EN 10.1.1. Rate and route of degradation 
including identification of the processes 
involved and identification of any 
metabolites and degradation products in at least three soil types under 
appropriate conditions Tier II  
10.1.2. Absorption and desorption in at 
least three soil types and, where 
relevant, absorption and desorption of 
metabolites and degradation products Tier II  
10.1.3. Mobility in at least three soil 
types and where relevant mobility of 
metabolites and degradation products Tier II  
10.1.4. Extent and nature of bound 
residues Tier II  
10.2. Fate and behaviour in water Tier II  
10.2.1. Rate and route of degradation in 
aquatic systems (as far as is not covered 
by section 7.2) including identification of metabolites and degradation products Tier II  
10.2.2. Absorption and desorption in 
water (soil sediment systems) and, 
where relevant, absorption and desorption of metabolites and 
degradation products Tier II  
10.3. Fate and behaviour in air 
If the active substance is to be used in 
mixtures for fumigants, if it is to be 
applied by a spray method, if it is 
volatile, or if any other information 
indicates that this is relevant, then the 
rate and route of degradation in air shall be determined as far as is not covered by 
section 7.4.3 Tier II  
11. Additional ecotoxicological studies Tier II 11. If the results of the ecotoxicological 
studies and the intended use(s) of the active substance indicate a danger for the 
environment then the tests described in this 
Section shall be conducted. 
11.1. Effects on birds Tier II  
11.1.1. Acute oral toxicity - this need not be done if an avian species was 
selected for study in section 7.4.1 Tier II  
11.1.2. Short-term toxicity - eight-day 
dietary study in at least one species (other than chickens) Tier II   
EN 123   EN 11.1.3. Effects on reproduction Tier II  
11.2. Effects on aquatic organisms Tier II  
11.2.1. Prolonged toxicity to an 
appropriate species of fish Tier II  
11.2.2. Effects on reproduction and 
growth rate on an appropriate species of fish Tier II  
11.2.3. Bioaccumulation in an 
appropriate species of fish Tier II  
11.2.4. Daphnia magna reproduction 
and growth rate Tier II  
11.3. Effects on other non-target 
organisms Tier II  
11.3.1. Acute toxicity to honeybees and 
other beneficial arthropods, e.g. predators. A different test organism 
shall be chosen from that used in section 
7.4.1 Tier II  
11.3.2. Toxicity to earthworms and to 
other soil non-target macro-organisms Tier II  
11.3.3. Effects on soil non-target micro-
organisms Tier II  
11.3.4. Effects on an y other specific, 
non-target organisms (flora and fauna) believed to be at risk Tier II  
12. Classification and labelling   
13. Summary and evaluation of 
Sections 1 to 12    
EN 124   EN TITLE  2 - MICRO -ORGANISMS  
Dossiers shall be prepared on strain level of  the micro-organism unless information is 
submitted that shows that the species is known to be sufficiently homogeneous regarding all characteristics, or the appli cant provides other arguments. 
Where the micro-organism has been genetically modified within the meaning of Article 2(2) 
of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate 
release into the environment of genetically modified orga nisms and repealing Council 
Directive 90/220/EEC
56, a copy of the evaluation of the da ta concerning the assessment of the 
risks to the environment as established in Artic le 4(2) of that Directive, shall also be 
submitted. 
If the biocidal product action is known to be partly or entirely due to the effect of a 
toxin/metabolite, or if significan t residues of toxins/metabolites are to be expect ed not related 
to the effect of the active micro-organism, a dossier for the toxin/metabolite shall be 
submitted in accordance with th e requirements of Title 1. 
The following data will be required to support submissions. 1. Identity of the micro-organism 1.1. Applicant 1.2. Manufacturer 1.3. Name and species descrip tion, strain characterisation 
1.3.1. Common name of the micro-or ganism (including alternative and superseded names) 
1.3.2. Taxonomic name and strain indicating whether it  is a stock variant, a mutant strain or 
a genetically modified organism (GMO); for viruses, taxonomic designation of the 
agent, serotype, strain or mutant 
1.3.3. Collection and culture reference num ber where the culture is deposited 
1.3.4. Methods, procedures and criteria used to establish the presence and identity of the 
micro-organism (e.g. morphology, biochemistry, serology, etc.) 
1.4. Specification of the material used fo r manufacturing of formulated products 
1.4.1. Content of the micro-organism 1.4.2. Identity and content of impurities, a dditives, contaminating micro-organisms 
1.4.3. Analytical profile of batches 2. Biological properties of the micro-organism 
                                                
 
56 OJ L 106, 17.4.2001, p. 1  
EN 125   EN 2.1. History of the micro-organism and its uses. Natural occurrence and geographical 
distribution 
2.1.1. Historical background 2.1.2. Origin and natural occurrence 2.2. Information on target organism(s) 2.2.1. Description of the target organism(s) 2.2.2. Mode of action 2.3. Host specificity range and effects on sp ecies other than the target organism 
2.4. Development stages/life cy cle of the micro-organism 
2.5. Infectiveness, dispersa l and colonisation ability 
2.6. Relationships to known plant or  animal or human pathogens 
2.7. Genetic stability and factors affecting it 2.8. Information on the production of metabolites (especially toxins) 2.9. Antibiotics and other anti-microbial agents 2.10. Robustness to environmental factors 2.11. Effects on materials, substances and products 
3. Additional information on the micro-organism 3.1. Function 3.2. Field of use envisaged 3.3. Product type(s) and category of users for wh ich the micro-organism should be listed 
in Annex I  
3.4. Method of production and quality control 3.5. Information on the occurrence or possi ble occurrence of th e development of 
resistance of the target organism(s) 
3.6. Methods to prevent loss of virulence of seed stock of the micro-organism 
3.7. Recommended methods and precautions con cerning handling, storage, transport or 
fire 
3.8. Procedures for destruction or decontamination 3.9. Measures in case of an accident  
EN 126   EN 3.10. Procedures for waste management 
3.11. Monitoring plan to be used for the active micro-organism including handling, 
storage, transport and use 
3.12. Classification of the micro-organism in the relevant risk group specified in Article 2 
of Directive 2000/54/EC 
4. Analytical methods 4.1. Methods for the analysis of the micro-organism as manufactured 
4.2. Methods to determine and quantif y residues (viable or non-viable) 
5. Effects on human health TIER I 5.1. Basic information 5.1.1. Medical data 5.1.2. Medical surveillance on ma nufacturing plant personnel 
5.1.3. Sensitisation/allerge nicity observations 
5.1.4. Direct observation, e.g. clinical cases 
5.2. Basic studies 5.2.1. Sensitisation 5.2.2. Acute toxicity, pathogenicity, and infectiveness 5.2.2.1. Acute oral toxicity, path ogenicity and infectiveness 
5.2.2.2. Acute inhalation toxicity, pa thogenicity and infectiveness 
5.2.2.3. Intraperitoneal/subc utaneous single dose 
5.2.3. In vitro genotoxicity testing 5.2.4. Cell culture study 5.2.5. Information on short-term toxicity and pathogenicity 
5.2.5.1. Health effects after repe ated inhalatory exposure 
5.2.6. Proposed treatment: first aid measures, medical treatment 
5.2.7. Any pathogenicity and infectiveness to  humans and other mammals under conditions 
of immunosuppression  
EN 127   EN END OF TIER I 
TIER II 5.3. Specific toxicity, pathogenic ity and infectiveness studies 
5.4. Genotoxicity — In vivo st udies in somatic cells 
5.5. Genotoxicity — In vivo studies in germ cells 
END OF TIER II 5.6. Summary of mammalian toxicity, pathoge nicity and infectiveness and overall 
evaluation 
6. Residues in or on treated mate rials, food and feedingstuffs 
6.1. Persistence and likelihood of  multiplication in or on treated  materials, feedingstuffs 
or foodstuffs 
6.2. Further information required 6.2.1. Non-viable residues 6.2.2. Viable residues 6.3. Summary and evaluation of residues in  or on treated materials, food and 
feedingstuffs 
7. Fate and behaviour in the environment 7.1. Persistence and multiplication 7.1.1. Soil 7.1.2. Water 7.1.3. Air 7.2. Mobility 7.3. Summary and evaluation of fate and behaviour in the environment 
8. Effects on non-target organisms 8.1. Effects on birds 
8.2. Effects on aquatic organisms 
8.2.1. Effects on fish 8.2.2. Effects on freshwater invertebrates  
EN 128   EN 8.2.3. Effects on algae growth 
8.2.4. Effects on plants other than algae 8.3. Effects on bees 8.4. Effects on arthropods other than bees 8.5. Effects on earthworms 8.6. Effects on soil micro-organisms 8.7. Further studies 8.7.1. Terrestrial plants 8.7.2. Mammals 8.7.3. Other relevant sp ecies and processes 
8.8. Summary and evaluation of ef fects on non-target organisms 
9. Summary and evaluation of sections 1 to  8 including conclu sions of the risk 
assessment and recommendations  
EN 129   EN ANNEX III  
 
Data requirements for biocidal products  
1. Dossiers on product shall contain the in formation needed to establish, where 
relevant, Acceptable Daily Intake (ADI), Acceptable Operator Exposure Level (AOEL), Predicted Environmental Concen tration (PEC) and Predicted No-Effect 
Concentration (PNEC). 
2. Information which is however not necessary  owing to the nature of the biocidal 
product or of its proposed uses need not be supplied.  
3. A detailed and full description of the studies  conducted and of the methods used or a 
bibliographical reference to thos e methods shall be included.  
4. The formats made available by the Commi ssion must be used for submission of the 
dossiers. In addition, the special software  package (IUCLID) made available by the 
Commission must be used for those parts of  the dossiers to which IUCLID applies. 
Formats and further guidance on data re quirements and dossier preparation are 
available on the Agency homepage. 
5. Tests submitted for the purpose of authorisat ion shall be conducted according to the 
methods described in Regulation (EC)  No 440/2008. However, if a method is 
inappropriate or not describe d, other methods shall be used which are, whenever 
possible, internationally r ecognised and must be justif ied in the application.  
6. Tests performed should comply with the relevant requirements of protection of 
laboratory animals, set out in Council Di rective 86/609/EEC on the approximation of 
laws, regulations and administrative provisi ons of the Member States regarding the 
protection of animals used for experi mental and other scientific purposes
57, and, in 
the case of ecotoxicological and toxicologica l tests, good laboratory practice, set out 
in Directive 2004/10/EC of the European  Parliament and of the Council on the 
harmonisation of laws, regulations and admi nistrative provisions relating to the 
application of the principles  of good laboratory practice an d the verification of their 
application for tests on chemical substances58 or other international standards 
recognised as being equivalent by the Commission or the Agency. 
7. Where testing is done, a detailed descripti on (specification) of th e material used and 
its impurities must be provided. Where necessary, data as established in Annex II shall be required for all the toxicologica lly/eco-toxicologically relevant chemical 
components of the biocidal product, in partic ular if the components  are substances of 
concern as defined in Article 3. 
8. Where test data exist that have been generated before ... [OJ: insert the date referred 
to in the first subparagraph of Article 85]  by methods other than those laid down in 
Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new te sts according to the Regulation (EC) No 
                                                
 
57 OJ L 358, 18.12.1986, p. 1. 
58 OJ L 50, 20.2.2004, p. 44.  
EN 130   EN 440/2008 must be decided by the competent authority of the Member State, on a 
case-by-case basis, taking into account, am ong other factors, the need to minimise 
testing on vertebrate animals. 
9. All available relevant knowledge and info rmation in literature should be provided.  
EN 131   EN TITLE 1 – Chemical products 
Dossier requirements  
  The following data will be required to support submissions. 1. Applicant  1.1. Name and address, etc. 1.2. Formulator of the biocidal product and th e active substance(s) (names, addresses, 
including location of plant(s)) 
2. Identity  2.1. Trade name or proposed trade name, and manufacturer's development code number 
of the preparation, if appropriate 
2.2. Detailed quantitative and qualitative inform ation on the composition of the biocidal 
product, e.g. active substance(s), impur ities, adjutants, inert components 
2.3. Physical state and nature of the biocidal  product, e.g. emulsifiable concentrate, 
wettable powder, solution 
3. Physical, chemical and technical properties  3.1. Appearance (physical state, colour) 3.2. Explosive properties 3.3. Oxidising properties 3.4. Flash-point and other indications of  flammability or spontaneous ignition 
3.5. Acidity/alkalinity and if necessa ry pH value (1 % in water) 
3.6. Relative density 3.7. Storage stability - stability and shelf-life. Effects of light, temperature and humidity 
on technical characteristics of the bioc idal product; reactivity towards container 
material 
3.8. Technical characteristics of  the biocidal product, e.g. we ttability, persistent foaming, 
flowability, pourability and dustability 
3.9. Physical and chemical compatibility w ith other products including other biocidal 
products with which its use is to be authorised 
4. Methods of identification and analysis  
EN 132   EN 4.1. Analytical method for determining the concen tration of the active substance(s) in the 
biocidal product 
4.2. In so far as not covered by Annex II, Section 4.2, analytical methods including 
recovery rates and the limits of determination for toxicologically and ecotoxicologically relevant components of the biocidal product and/or residues 
thereof, where relevant in or on the following: 
4.2.1. Soil 4.2.2. Air 4.2.3. Water (including drinking water) 4.2.4. Animal and human body fluids and tissues 4.2.5. Treated food or feedingstuffs 5. Intended uses and efficacy  5.1. Product type and field of use envisaged 5.2. Method of application including description of system used 
5.3. Application rate and if a ppropriate, the final concentra tion of the biocidal product 
and active substance in the system in which the preparation is to be used, e.g. cooling 
water, surface water, water used for heating purposes 
5.4. Number and timing of applications, and wh ere relevant, any particular information 
relating to geographical varia tions, climatic variations, or necessary waiting periods 
to protect man and animals 
5.5. Function, e.g. fungicide, rodentic ide, insecticide, bactericide 
5.6. Pest organism(s) to be controlled and pr oducts, organisms or objec ts to be protected 
5.7. Effects on target organisms 5.8. Mode of action (including time delay) in so far as not covered by Annex II, Section 
5.4 
5.9. User: industrial, professional, general public (non-professional) 
5.10. The proposed label claims for the product  5.11. Efficacy data to support these claims, including any available standard protocols 
used, laboratory tests, or fi eld trials, where appropriate 
5.12. Any other known limitations on efficacy including resistance 6. Toxicological studies 6.1. Acute toxicity  
EN 133   EN For studies of Sections 6.1.1 to 6.1.3, biocid al products other than gases shall be 
administered via at least two routes, one of which should be the oral route. The 
choice of the second route will depend on th e nature of the pr oduct and the likely 
route of human exposure. Gases and volatil e liquids should be administered by the 
inhalation route 
6.1.1. Oral 6.1.2. Dermal 6.1.3. Inhalation 6.1.4. For biocidal products that are intended to be authorised for use with other biocidal 
products, the mixture of products, where possi ble, shall be tested for acute dermal 
toxicity and skin and eye irritation, as appropriate 
6.2. Skin and eye irritation
59 
6.3. Skin sensitisation 6.4. Information on dermal absorption 6.5. Available toxicological data relating to toxicologically relevant non-active 
substances (i.e. substances of concern) 
6.6. Information related to the exposure of th e biocidal product to man and the operator 
Where necessary, the test(s) described in Annex II, shall be required for the 
toxicologically relevant non-active substances of the preparation 
7. Ecotoxicological studies 7.1. Foreseeable routes of entry into the e nvironment on the basis of the use envisaged 
7.2. Information on the ecotoxicology of the ac tive substance in the product, where this 
cannot be extrapolated from the info rmation on the active substance itself 
7.3. Available ecotoxicological information re lating to ecotoxicological relevant non-
active substances (i.e. substances of concer n), such as information from safety data 
sheets 
8. Measures to be adopted to protect man, animals and the environment 8.1. Recommended methods and precautions conc erning handling, use, storage, transport 
or fire 
8.2. Specific treatment in case of an accident, e.g. first-aid measures, antidotes, medical 
treatment if available; emergency measures to protect the environment; in so far as 
not covered by Annex II, Title1, point 8.3 
                                                
 
59 Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential 
corrosive properties.  
EN 134   EN 8.3. Procedures, if any, for cl eaning application equipment 
8.4. Identity of relevant combusti on products in cases of fire 
8.5. Procedures for waste management of th e biocidal product a nd its packaging for 
industry, professional users and the general public (non- professional users), e.g. 
possibility of reuse or recyc ling, neutralisation,  conditions for cont rolled discharge, 
and incineration 
8.6. Possibility of destruction or decont amination following release in or on the 
following: 
8.6.1. Air 8.6.2. Water, including drinking water 8.6.3. Soil 8.7. Observations on undesirable or unintended side-effects, e.g. on be neficial and other 
non-target organisms 
8.8. Specify any repellents or poison control meas ures included in the preparation that are 
present to prevent action ag ainst non-target organisms 
9. Where relevant, the following additi onal data shall also be provided 
9.1. Further human health-related studies 9.1.1. Food and feedingstuffs studies 9.1.1.1. If residues of the biocidal  product remain on feedingstuffs  for a significant period of 
time, then feeding and metabolism studies in  livestock shall be required to permit 
evaluation of residues in food of animal origin 
9.1.1.2. Effects of industrial processing and/or  domestic preparation on the nature and 
magnitude of residues of the biocidal product 
9.1.2. Other test(s) related to  the exposure to humans 
Suitable test(s) and a reasoned case will be required for the biocidal product 
9.2. Further studies on fate and be haviour in the environment  
9.2.1. Where relevant all the informati on required in Annex II, Section 12 
9.2.2. Testing for distribution and dissipation in the following: 
9.2.2.1. Soil 9.2.2.2. Water 9.2.2.3. Air  
EN 135   EN Test requirements 1 and 2 a bove are applicable only to ecotoxicologically relevant 
components of the biocidal product 
9.3. Further Ecotoxicological studies  9.3.1. Effects on birds 9.3.1.1. Acute oral toxicity, if not already d one in accordance with Annex II, Section 7 
9.3.2. Effects on aquatic organisms 9.3.2.1. In case of application on, in, or near to surface waters 9.3.2.1.1. Particular studies with fish  and other aquatic organisms 
9.3.2.1.2. Residue data in fish co ncerning the active substance and including toxicologically 
relevant metabolites 
9.3.2.1.3. The studies referred to in Annex II, Section 13.2.1, 2.2, 2.3 and 2.4 may be required 
for relevant components of the biocidal product 
9.3.2.1.4. If the biocidal product is to be sprayed near to surface waters then an overspray 
study may be required to assess risks to aquatic organisms under field conditions 
9.3.3. Effects on other non-target organisms 9.3.3.1. Toxicity to terrestrial ve rtebrates other than birds 
9.3.3.2. Acute toxicity to honeybees 9.3.3.3. Effects on beneficial arthropods other than bees 9.3.3.4. Effects on earthworms and other soil non-targ et macro-organisms, believed to be at 
risk 
9.3.3.5. Effects on soil non-target micro-organisms 9.3.3.6. Effects on any other specific, non-target orga nisms (flora and fauna) believed to be at 
risk 
9.3.3.7. If the biocidal pr oduct is in the form of bait or granules 
9.3.3.7.1. Supervised trials to as sess risks to non-target orga nisms under field conditions 
9.3.3.7.2. Studies on acceptance by i ngestion of the biocidal product by any non-target 
organisms thought to be at risk 
10. Classification, packaging and labelling 
– Proposals for safety-data sh eets, where appropriate 
– Hazard symbol(s)  
EN 136   EN – Indications of danger 
– Hazard statements 
– Precautionary statements 
– Packaging (type, materials, size, etc.), compatibility of the preparation with 
proposed packaging materials to be included 
11. Summary and evaluation of Sections 2 to 10  
EN 137   EN TITLE  2 – MICRO -ORGANISMS  
Dossier requirements 
  The following data will be required to support submissions. 1. Applicant  1.1. Name and address, etc. 1.2. Formulator of the biocidal product and the micro-organism(s) (names, addresses, 
including location of plant(s)) 
2. Identity of the biocidal products 2.1. Trade name or proposed trade name, and manufacturer's development code number 
of the biocidal product 
2.2. Detailed quantitative and qualitative inform ation on the composition of the biocidal 
product 
2.3. Physical state and nature  of the biocidal product 
2.4. Function 3. Physical, chemical and technical properties of the biocidal product 
3.1. Appearance (colour and odour) 3.2. Storage stability and shelf-life 3.2.1. Effects of light, temperature and humidity on technical characteristics of the biocidal 
product 
3.2.2. Other factors affecting stability 3.3. Explosivity and oxi dising properties 
3.4. Flash point and other indications of  flammability or spontaneous ignition 
3.5. Acidity, alkalinity and pH value 3.6. Viscosity and surface tension 
3.7. Technical characteristic s of the biocidal product 
3.7.1. Wettability 3.7.2. Persistent foaming  
EN 138   EN 3.7.3. Suspensibility and suspension stability 
3.7.4. Dry sieve test and wet sieve test 3.7.5. Particle size distribution (dustable a nd wettable powders, granules), content of 
dust/fines (granules), attrition and friability (granules) 
3.7.6. Emulsifiability, re-emulsif iability, emulsion stability 
3.7.7. Flowability, pourability (rin sability) and dustability 
3.8. Physical, chemical and biological compatibility with other products including 
biocidal products with which its use is to be authorised or registered 
3.8.1. Physical compatibility 3.8.2. Chemical compatibility 3.8.3. Biological compatibility 3.9. Summary and evaluation of physical, chem ical and technical properties of the 
biocidal product 
4. Analytical methods 4.1. Methods for the analysis of the biocidal product 4.2. Methods to determine and quantify residues 5. Intended use and efficacy 5.1. Field of use envisaged 5.2. Mode of action 5.3. Details of intended use 5.4. Application rate 5.5. Content of micro-organism in material used  (e.g. in the application device or bait) 
5.6. Method of application 5.7. Number and timing of applica tions and durati on of protection 
5.8. Necessary waiting periods or other precauti ons to avoid adverse effects to human and 
animal health and the environment 
5.9. Proposed instructions for use 5.10. Category of users 5.11. Information on the possible occurren ce of the development of resistance  
EN 139   EN 5.12. Effects on the materials or products  treated with the biocidal product 
6. Effects on human health 6.1. Basic acute toxicity studies 6.1.1. Acute oral toxicity 6.1.2. Acute inhalation toxicity 6.1.3. Acute percutaneous toxicity 6.2. Additional acute toxicity studies 6.2.1. Skin irritation 6.2.2. Eye irritation 6.2.3. Skin sensitisation 6.3. Data on exposure 6.4. Available toxicological data relating to non-active substances 
6.5. Supplementary studies for comb inations of biocidal products 
6.6. Summary and evaluation of effects on human health 7. Residues in or on treated mate rials, food and feedingstuffs 
8. Fate and behaviour in the environment 9. Effects on non-target organisms 9.1. Effects on birds 9.2. Effects on aquatic organisms 9.3. Effects on bees 9.4. Effects on arthropods other than bees 9.5. Effects on earthworms 9.6. Effects on soil micro-organisms 9.7. Additional studies on additional species or  higher tier studies such as studies on 
selected non-target organisms 
9.7.1. Terrestrial plants 
9.7.2. Mammals 9.7.3. Other relevant sp ecies and processes  
EN 140   EN 9.8. Summary and evaluation of ef fects on non-target organisms 
10. Classification, packaging and labelling 
As established in point b of Article 18(1) , proposals including justification for the 
hazard and precautionary statements in accordance with the provisions set in Regulation (EC) No 1272/2008 and Directiv e 1999/45/EC must be submitted. The 
classification comprises of the descripti on of the category/categories of danger and 
qualifying hazard statements for all dangerous properties.  
10.1. Packaging and compatibility of the bi ocidal product with proposed packaging 
materials 
10.2. Procedures for cleaning application equipment 10.3. Re-entry periods, necessary waiting periods  or other precautions to protect man, 
livestock and the environment 
10.4. Recommended methods and precautions con cerning: handling, storage, transport or 
fire 
10.5. Measures in the case of an accident 10.6. Procedures for destructi on or decontamination of the biocidal product and its 
packaging 
10.6.1. Controlled incineration 10.6.2. Others 10.7. Monitoring plan to be used for th e active micro-organi sm and other micro-
organism(s) contained in the biocidal pr oduct including handling, storage, transport 
and use 
10.8. Indication on the need for biocidal produc t to carry the biohazard sign specified in 
Annex II to Directive 2000/54/EC 
11. Summary and evaluation of Sections 1 to  10 including conclusions of the risk 
assessment and recommendations  
EN 141   EN ANNEX IV  
 
GENERAL RULES FOR THE ADAPTATION OF THE DATA REQUIREMENTS  
The applicant may propose to adapt the data requirements set out in Annexes II and III 
according to the general rules set out in this Annex. The reasons for such adaptations to the 
data requirements must be clearl y stated under the appropriate h eading of the dossier referring 
to the specific rule (s) of this Annex. 
1. TESTING  DOES  NOT  APPEAR  SCIENTIFICALLY  NECESSARY 
1.1. Use of existing data 
1.1.1. Data on physical-chemical properties from experiments not carried out according to 
GLP or the relevant test methods. 
Data shall be considered to be equivalent  to data generated by the corresponding test 
methods if the following conditions are met: 
(1) adequacy for the purpose of classifi cation and labelling and risk assessment; 
(2) sufficient documentation is provided to  assess the adequacy of the study; and 
(3) the data are valid for the endpoin t being investigated  and the study is 
performed using an acceptable level of quality assurance.  
1.1.2. Data on human health and environmental pr operties from exper iments not carried 
out according to GLP or th e relevant test methods. 
Data shall be considered to be equivalent  to data generated by the corresponding test 
methods if the following conditions are met: 
(1) adequacy for the purpose of classifi cation and labelling and risk assessment; 
(2) adequate and reliable coverage of  the key parameters foreseen to be 
investigated in the co rresponding test methods; 
(3) exposure duration comparable to or l onger than the corres ponding test methods 
if exposure duration is a relevant parameter; and 
(4) adequate and reliable document ation of the study is provided. 
1.1.3. Historical human data 
Historical human data, such as epidem iological studies on exposed populations, 
accidental or occupational exposure data, bi omonitoring studies, clinical studies and 
human volunteer studies performed in acco rdance with internationally accepted 
ethical standards shall be considered. The strength of the data for a specific human 
health effect depends, among other things , on the type of analysis and on the 
parameters covered and on the magnitude  and specificity of the response and  
EN 142   EN consequently the predictability of the eff ect. Criteria for assessing the adequacy of 
the data include: 
(1) the proper selection and characterisa tion of the exposed and control groups; 
(2) adequate characteri sation of exposure; 
(3) sufficient length of follow-up for disease occurrence; (4) valid method for observing an effect; (5) proper consideration of bias and confounding factors; and (6) a reasonable statis tical reliability to justify the conclusion. 
In all cases adequate and reliable  documentation shall be provided. 
1.2. Weight of evidence  
There may be sufficient weight of eviden ce from several independent sources of 
information leading to the assumption/conclu sion that a substance has or has not a 
particular dangerous property, while the in formation from each single source alone is 
regarded insufficient to s upport this notion. There may be sufficient weight of 
evidence from the use of newly developed test methods, not yet included in the 
relevant test methods or from an in ternational test method recognised by the 
Commission as being equivalent, leading to  the conclusion that a substance has or 
has not a particular dangerous property.  
Where sufficient weight of evidence for the presence or absence of a particular 
dangerous property is available: 
– further testing on vertebrate animals for that property shall be omitted, 
– further testing not involving vertebrate animals may be omitted. 
In all cases adequate and reliable  documentation shall be provided. 
1.3. Qualitative or Quantita tive structure-activity relationship ((Q)SAR) 
Results obtained from valid qualitative or quantitative structure-activity relationship 
models ((Q)SARs) may indica te the presence or absenc e of a certain dangerous 
property. Results of (Q)SAR s may be used instead of testing when the following 
conditions are met: 
– results are derived from a (Q)SAR mode l whose scientific validity has been 
established, 
– the substance falls within the applic ability domain of the (Q)SAR model, 
– results are adequate for the purpose of  classification and labelling and risk 
assessment, and 
– adequate and reliable documentati on of the applied method is provided.  
EN 143   EN 1.4. In vitro methods 
Results obtained from suitable in vitro methods may indicate the presence of a 
certain dangerous property or may be important in relation to a mechanistic understanding, which may be important for the assessment. In this context, ‘suitable’ 
means sufficiently well developed accordin g to internationally agreed test 
development criteria. 
Such confirmation may be waived, if the following conditions are met: 
(1) results are derived from an in vitro method whose scientific validity has been 
established by a validation study, according to internationally agreed validation 
principles; 
(2) results are adequate for the purpose of classification and labelling and risk 
assessment; and 
(3) adequate and reliable documenta tion of the applied method is provided. 
1.5. Grouping of substances and read-across approach 
Substances whose physicochemical, toxicologi cal and ecotoxicolog ical properties are 
likely to be similar or follow a regular pattern  as a result of structural similarity may 
be considered as a group, or ‘category’ of substances. Application of the group 
concept requires that physicochemical pr operties, human health effects and 
environmental effects or environmental fate may be predicted from data for reference 
substance(s) within the group by interpolation to other s ubstances in the group (read-
across approach). This avoids the need to  test every substance for every endpoint. 
The similarities may be based on: 
(1) a common functional group; (2) the common precursors and/or th e likelihood of comm on breakdown products 
via physical and biological processes, which result in structurally similar 
chemicals; or 
(3) a constant pattern in the changing of  the potency of the properties across the 
category. 
If the group concept is app lied, substances shall be cla ssified and labelled on this 
basis. 
In all cases results should: – be adequate for the purpose of classifi cation and labelling an d risk assessment, 
– have adequate and reliable coverage of the key parameters addressed in the 
corresponding test method, 
– cover an exposure duration comparable to or longer than the corresponding test 
method if exposure duration is a relevant parameter, and  
EN 144   EN – adequate and reliable documentation of  the applied method shall be provided. 
2. TESTING  IS TECHNICALLY  NOT  POSSIBLE 
Testing for a specific endpoint may be omitte d, if it is technica lly not possible to 
conduct the study as a consequence of the pr operties of the subs tance: e.g. very 
volatile, highly reactive or unstable subs tances cannot be used, mixing of the 
substance with water may cause danger of fire  or explosion or the radio-labelling of 
the substance required in certain studies ma y not be possible. The guidance given in 
the relevant test methods, more specifically on the technical limita tions of a specific 
method, shall always be respected.  
3. PRODUCT-TAILORED  EXPOSURE-DRIVEN  TESTING 
3.1. Testing in accordance with sections 6 and 7 of Annexes II and III may be omitted 
based on exposure considerations.  
3.2. In all cases, adequate justificatio n and documentation shall be provided. The 
justification shall be based on an e xposure assessment in accordance with the 
Technical Notes for Guidance.  
EN 145   EN ANNEX V  
 
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN 
ARTICLE 2(1)  
These product-types exclude products where they are covered by the Directives mentioned in 
Article 2(2) for the purpo ses of those Directives. 
MAIN GROUP 1: Disinfectants a nd general biocidal products  
These product types exclude cleaning products that  are not intended to have a biocidal effect, 
including washing liquids, pow ders and similar products. 
Product-type 1: Human hygi ene biocidal products 
Products in this group are biocidal produc ts used for human hygiene purposes. 
Product-type 2: Private area and public health area disinfectants  and other biocidal products 
Products used for the disinfecti on of air, surfaces, materials, equipment and furniture which 
are not used for direct food or feedingstuffs contact in pr ivate, public and industrial areas, 
including hospitals, as well as products used as algaecides. 
Usage areas include, inter alia, swimming pools,  aquariums, bathing and other waters; air-
conditioning systems; walls and floors in health  and other institutions; chemical toilets, waste 
water, hospital waste, soil or ot her substrates (in playgrounds). 
Product-type 3: Veterinary hygiene biocidal products 
Products in this group are bioc idal products used for veteri nary hygiene purposes including 
products used in areas in which anim als are housed, kept or transported. 
Product-type 4: Food and feed area disinfectants 
Products used for the disinfection of equipment,  containers, consumption utensils, surfaces or 
pipework associated with th e production, transport, stor age or consumption of food, 
feedingstuffs or drink (i ncluding drinking water) for humans and animals. 
Product-type 5: Drinking water disinfectants Products used for the disinfection of dri nking water (for both humans and animals). 
MAIN GROUP 2: Preservatives  
Product-type 6: In-can preservatives 
Products used for the preservation of manuf actured products, other than foodstuffs or 
feedingstuffs, in containers by the control of micr obial deterioration to ensure their shelf life. 
Product-type 7: Film preservatives  
EN 146   EN Products used for the preservation of film s or coatings by the control of microbial 
deterioration in order to protec t the initial properties of the surface of materials or objects such 
as paints, plastics, sealants, wall adhe sives, binders, papers, art works. 
Product-type 8: Wood preservatives Products used for the preservation of wood, fr om and including the saw-mill stage, or wood 
products by the control of wood-destr oying or wood-disfiguring organisms. 
This product type includes both pr eventive and curative products. 
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives 
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber 
or paper or textile products and rubber by th e control of microbiol ogical deterioration. 
Product-type 10: Masonry preservatives Products used for preservation and remedial treatment of masonry or other construction 
materials other than wood by the contro l of microbiological and algal attack. 
Product-type 11: Preservatives for li quid-cooling and processing systems 
Products used for the preservati on of water or other liquids us ed in cooling and processing 
systems by the control of harmful organisms such as microbes, algae and mussels. 
Products used for the preservation of drinking water are not included in this product type. 
Product-type 12: Slimicides 
Products used for the prevention or control of  slime growth on materials, equipment and 
structures, used in industrial processes, e.g. on wood and paper pulp, porous sand strata in oil 
extraction. 
Product-type 13: Metalwor king-fluid preservatives 
Products used for the preservation of meta lworking fluids by the control of microbial 
deterioration. 
MAIN GROUP 3: Pest control  
Product-type 14: Rodenticides 
Products used for the control of mice, rats or other rodents. Product-type 15: Avicides Products used for the control of birds. Product-type 16: Molluscicides Products used for the control of molluscs.  
EN 147   EN Product-type 17: Piscicides 
Products used for the control of fish; these produ cts exclude products for the treatment of fish 
diseases. 
Product-type 18: Insecticides, acaricides and products to control other arthropods 
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans). 
Product-type 19: Repellents and attractants Products used to control harmful organisms (invertebrates such  as fleas, vertebrates such as 
birds), by repelling or attracting, including thos e that are used for human or veterinary 
hygiene either direct ly or indirectly. 
MAIN GROUP 4: Other biocidal products  
Product-type 20: - 
Product-type 21: Antifouling products Products used to control the gr owth and settlement of fouli ng organisms (microbes and higher 
forms of plant or animal species) on vessels, aqu aculture equipment or other structures used in 
water. 
Product-type 22: Embalming and taxidermist fluids Products used for the disinfectio n and preservation of human or  animal corpses, or parts 
thereof. 
Product-type 23: Control of other vertebrates 
Products used for the control of vermin.  
EN 148   EN ANNEX VI  
 
COMMON PRINCIPLES FOR THE EVALUAT ION OF DOSSIERS FOR BIOCIDAL 
PRODUCTS  
DEFINITIONS 
(a) Hazard identification 
This is the identification of the adverse effects which a biocidal product has an 
inherent capacity to cause. 
(b) Dose (concentration) - response (effect) assessment 
This is the estimate of the relationship betw een the dose, or level of exposure, of an 
active substance or substance of concern in  a biocidal product and the incidence and 
severity of an effect. 
(c) Exposure assessment 
This is the determination of the emissions , pathways and rates of movement of an 
active substance or a substance of c oncern in a biocidal product and its 
transformation or degradation in order to estimate the concentration/doses to which 
human populations, animals or environmenta l compartments are or may be exposed. 
(d) Risk characterisation 
This is the estimation of the incidence and severity of the adverse effects likely to 
occur in a human population, animals or en vironmental compartments due to actual 
or predicted exposure to any active substan ce or substance of concern in a biocidal 
product. This may include 'risk estimation` i.e. the quantificati on of that likelihood. 
(e) Environment 
Water, including sediment, air, land, wild  species of fauna and flora, and any 
interrelationship between them, as well as  any relationship with living organisms. 
INTRODUCTION   
1. This Annex lays down principles to ensure  that evaluations made  and decisions taken 
by a competent authority or the Agenc y, or the Commission, where relevant, 
concerning the authorisation of a bioc idal product providing it is a chemical 
preparation results in a harmonised high le vel of protection for humans, animals and 
the environment in accordance with  point (b) of Article 16(1). 
2. In order to ensure a high and harmonise d level of protection of human and animal 
health and of the environment, any risks arising from the use of a biocidal product 
shall be identified. To achieve this, a risk assessment shall be carried out to determine the acceptability or otherwise of  any risks identified during the proposed  
EN 149   EN normal use of the biocidal product. This is  done by carrying out an assessment of the 
risks associated with the relevant indi vidual components of the biocidal product. 
3. A risk assessment on the active substance or substances presen t in the biocidal 
product is always required. This will alrea dy have been carried out for the purpose of 
the inclusion of the active substance into Annex I. This risk assessment shall entail 
hazard identification, and, as appropriate, dose (concentration) - response (effect) 
assessment, exposure assessment and risk ch aracterisation. Where a quantitative risk 
assessment cannot be made a qualita tive assessment shall be produced. 
4. Additional risk assessments shall be carried out, in the same manner as described 
above, on any other substance of concern present in the biocidal product where 
relevant for the use of  the biocidal product. 
5. In order to carry out a risk  assessment data are required . These data are detailed in 
Annexes II, III and IV and, recognising that there are a wide variety of product types, are flexible according to the product type and associated risks. The data required 
shall be the minimum necessary to carry  out an appropriate risk assessment. 
Competent authorities or the Agency should take due consideration of the 
requirements of Article 6 and Article 19 of this Regulation in order to avoid 
duplication of data submissions. The mini mum set of data required for an active 
substance in any biocidal product type, howev er, shall be that detailed in Annex VI 
to Regulation (EC) No 1907/2006; these data  will already have been submitted and 
assessed as part of the risk assessment requ ired for entry of the active substance into 
Annex I to this Regulation. Data may also be required on a substance of concern 
present in a biocidal product. 
6. The results of the risk assessments car ried out on an active substance and on a 
substance of concern present in the biocidal  product shall be inte grated to produce an 
overall assessment for the biocidal product itself. 
7. When making evaluations and taking decisi ons concerning the authorisation of a 
biocidal product the competent authorities or the Agency shall: 
(a) take into consideration other relevant technical or scientific information which 
is reasonably available to them with re gard to the propertie s of the biocidal 
product, its components, me tabolites, or residues; 
(b) evaluate, where relevant, justifications submitted by the applicant for not 
supplying certain data. 
8. It is known that many biocidal produc ts present only minor differences in 
composition and this should be taken into account when evaluating dossiers. The concept of 'frame-formula tions` is relevant here. 
9. It is known that certain biocidal products  are considered as posing only a low risk, 
these biocidal products, while complying with the requirements of this Annex, are 
subject to a simplified procedure as detail ed in Article 16(3) of this Regulation. 
10. The application of these comm on principles shall lead to the competent authorities or 
the Commission deciding whether or not a bi ocidal product can be authorised, such 
authorisation may include rest rictions on use or other condi tions. In cert ain cases the  
EN 150   EN competent authorities may conclude that  more data are required before an 
authorisation decision can be made. 
11. During the process of evaluation and deci sion-making, applicants and the competent 
authorities shall cooperate in order to re solve any questions on the data requirements 
quickly or to identify at an early stage any additional studies required, or to amend 
any proposed conditions for the use of the bioc idal product or to modify its nature or 
its composition in order to ensure full co mpliance with the requirements of Article 16 
and of this Annex. The administrative burde n, especially for small and medium-sized 
enterprises (SMEs), shall be kept to th e minimum necessary without prejudicing the 
level of protection afforded to humans, animals and the environment. 
12. The judgments made by the competent authorities during the evaluation and 
decision-making process must be based on  scientific principles, preferably 
recognised at international level, and be made with the benefit of expert advice. 
EVALUATION 
General principles 
13. The data submitted in support of an app lication for authorisation of a biocidal 
product shall be examined for overall scien tific value by the receiving competent 
authorities. After acceptance of these data the competent aut horities shall utilise them 
by carrying out a risk assessment based on th e proposed use of the biocidal product. 
14. A risk assessment on the active substance pr esent in the biocidal product shall always 
be carried out. If there are, in addition, any substances of concern present in the 
biocidal product then a risk assessment shall be carried out for each of these. The risk 
assessment shall cover the proposed normal us e of the biocidal pr oduct together with 
a realistic worst-case scenario including a ny relevant production and disposal issue 
either of the biocidal product itself  or any material treated with it. 
15. For each active substance and each substan ce of concern present in the biocidal 
product, the risk assessment sh all entail a hazard identification and the establishment 
of appropriate no-observed-a dverse-effect levels (NOAEL) , where possible. It shall 
also include, as appropriate, a dose (concen tration) - response (effect) assessment, 
together with an exposure assessment and a risk characterisation. 
16. The results arrived at from  a comparison of the expos ure to the no-effect level 
concentrations for each of the active substa nces and any substances of concern shall 
be integrated to produce an overall risk assessment for the biocidal product. Where 
quantitative results are not ava ilable the results of the qualitative assessments shall be 
integrated in a similar manner. 
17. The risk assessment shall determine: 
(a) the risk to humans and animals, (b) the risk to the environment,  
EN 151   EN (c) the measures necessary to prot ect humans, animals and the general 
environment during both the proposed nor mal use of the biocidal product and 
in a realistic worst-case situation. 
18. In certain cases it may be concluded that further data are required before a risk 
assessment can be finalised. Any such a dditional data request ed shall be the 
minimum necessary to complete such a risk assessment. 
Effects on humans  
19. The risk assessment shall take account of the following potential effects arising from 
the use of the biocidal product and the populations liable to exposure. 
20. The effects previously mentioned result from the properties of the active substance 
and any substance of concern present. They are: 
– acute and chronic toxicity, 
– irritation, 
– corrosivity, 
– sensitisation, 
– repeated dose toxicity, 
– mutagenicity, 
– carcinogenicity, 
– reproduction toxicity, 
– neurotoxicity, 
– any other special properties of the acti ve substance or substance of concern, 
– other effects due to physic o-chemical properties. 
21. The populations previously mentioned are: 
– professional users, 
– non-professional users, 
– humans exposed indirectly via the environment. 
22. The hazard identification sh all address the properties and potential adverse effects of 
the active substance and any s ubstances of concern present in the biocidal product. If 
this results in the biocidal product being classified according to the requirements of 
Article 58 then dose (concentration) - response (effect) assessment, exposure 
assessment and risk characterisation shall be required.  
EN 152   EN 23. In those cases where the te st appropriate to hazard iden tification in relation to a 
particular potential effect of an active subs tance or a substance of concern present in 
a biocidal product has been c onducted but the results have not lead to classification 
of the biocidal product then risk characterisa tion in relation to that  effect shall not be 
necessary unless there are other reas onable grounds for c oncern, e.g. adverse 
environmental effects or unacceptable residues. 
24. The competent authorities shall apply points 25 to 28 when carrying out a dose 
(concentration) - response (effect) assessm ent on an active substa nce or a substance 
of concern present in a biocidal product. 
25. For repeated dose toxicity and reproductiv e toxicity the dose response relationship 
shall be assessed for each active substa nce or substance of concern and, where 
possible, the no-observed-adverse-effect level (NOAEL) identified. If it is not 
possible to identify a NOAEL, the lowest -observed-adverse-effect level (LOAEL) 
shall be identified. 
26. For acute toxicity, corrosiv ity and irritation, it is not us ually possible to derive a 
NOAEL or LOAEL on the basis of test s conducted in accord ance with the 
requirements of this Regulation. For acute to xicity, the LD50 (median lethal dose) or 
LC50 (median lethal concentration) value or, where the fixed dose procedure has 
been used, the discriminating dose shall be derived. For the other effects it shall be 
sufficient to determine whether the active s ubstance or substance of concern has an 
inherent capacity to cause such effects during use of the product. 
27. For mutagenicity and carcinogenicity it sh all be sufficient to determine whether the 
active substance or substance of concern has an inherent capac ity to cause such 
effects during use of the biocid al product. However, if it can be demonstrated that an 
active substance or a substance of con cern identified as a carcinogen is non-
genotoxic, it will be appropr iate to identify a N(L)OAEL as described in point 25. 
28. With respect to skin sensitisation and respirat ory sensitisation, in so far as there is no 
consensus on the possibility of identifying a dose/concentration below which adverse effects are unlikely to occur in a subject al ready sensitised to a given substance, it 
shall be sufficient to evaluate whether th e active substance or substance of concern 
has an inherent capacity to cause such e ffects during use of th e biocidal product. 
29. Where toxicity data derived from observ ations of human exposure, e.g. information 
gained from manufacture, from poison centres or epidemiology surveys, are 
available special consideration shall be give n to those data when carrying out the risk 
assessment. 
30. An exposure assessment shall be carried out for each of the human populations 
(professional users, non-professional users and humans exposed indirectly via the 
environment) for which exposure to a bioc idal product occurs or can reasonably be 
foreseen. The objective of the assessment shall be to make a quantitative or 
qualitative estimate of the dose/concentra tion of each active substance or substance 
of concern to which a population is, or ma y be exposed during use of the biocidal 
product.  
EN 153   EN 31. The exposure assessment shall be based on the information in the technical dossier 
provided in conformity with Article 6 a nd Article 19 and on any other available and 
relevant information. Particular account  shall be taken, as appropriate, of: 
– adequately measured exposure data, 
– the form in which the product is marketed, 
– the type of biocidal product, 
– the application method and application rate, 
– the physico-chemical properties of the product, 
– the likely routes of exposur e and potential for absorption, 
– the frequency and duration of exposure, 
– the type and size of specific exposed populations where such information is 
available. 
32. Where adequately measured, representati ve exposure data are available, special 
consideration shall be gi ven to them when conducting the exposure assessment. 
Where calculation methods are used for the estimation of exposure levels, adequate 
models shall be applied. 
These models shall: 
– make a best possible estimation of all relevant processes taking into account 
realistic parameters and assumptions, 
– be subjected to an analysis taking into account possible elements of 
uncertainty, 
– be reliably validated with measurements carried out under circumstances 
relevant for the use of the model, 
– be relevant to the conditi ons in the area of use. 
Relevant monitoring data from substances  with analogous use a nd exposure patterns 
or analogous properties sha ll also be considered. 
33. Where, for any of the effects set ou t in point 20 a NOAEL or LOAEL had been 
identified, the risk charact erisation shall en tail comparison of the NOAEL or LOAEL 
with the evaluation of the dose/concen tration to which the population will be 
exposed. Where a NOAEL or LOAEL ca nnot be established a qualitative 
comparison shall be made. 
Effects on animals  
34. Using the same relevant principles as desc ribed in the section dealing with effects on 
humans, the competent authorities shall cons ider the risks posed to animals from the 
biocidal product.  
EN 154   EN Effects on the environment  
35. The risk assessment shall take account of any adverse effects arising in any of the 
three environmental compartments - air, so il and water (includi ng sediment) - and of 
the biota following the use of the biocidal product. 
36. The hazard identification sh all address the properties and potential adverse effects of 
the active substance and any s ubstances of concern present in the biocidal product. If 
this results in the biocidal product being classified according to the requirements of 
this Regulation then dose (concentration)  - response (effect) assessment, exposure 
assessment and risk characterisation shall be required. 
37. In those cases where the te st appropriate to hazard iden tification in relation to a 
particular potential effect of an active subs tance or a substance of concern present in 
a biocidal product has been c onducted but the results have no t led to classification of 
the biocidal product then risk characterisati on in relation to that effect shall not be 
necessary unless there are other reasonabl e grounds for concern. Such grounds may 
derive from the properties and effects of  any active substance or substance of 
concern in the biocidal product, in particular: 
– any indications of bioaccumulation potential, 
– the persistence characteristics, 
– the shape of the toxicity/time curve in ecotoxicity testing, 
– indications of other adverse effects on the basis of toxicity studies (e.g. 
classification as a mutagen), 
– data on structurally analogous substances, 
– endocrine effects. 
38. A dose (concentration) - response (effect) asse ssment shall be carried out in order to 
predict the concentration below which adverse effects in the environmental compartment of concern are not expected to occur. This shall be carried out for the 
active substance and for any substance of concern present in the biocidal product. 
This concentration is known as the pred icted no-effect concentration (PNEC). 
However, in some cases, it may not be possible to establish a PNEC and a qualitative estimation of the dose (concentration) - response (effect) then has to be made. 
39. The PNEC shall be determined from the data on effects on orga nisms and ecotoxicity 
studies submitted in accordance with requir ements of Article 6 and Article 18. It 
shall be calculated by applying an assessment factor to the values resulting from tests 
on organisms, e.g. LD50 (median lethal dos e), LC50 (median lethal concentration), 
EC50 (median effective concentration), IC 50 (concentration causing 50 % inhibition 
of a given parameter, e.g. growth),  NOEL(C) (no-observed-effect level 
(concentration)), or LOEL(C) (lowest-obs erved-effect level (concentration)). 
40. An assessment factor is an expression of the degree of uncertainty in extrapolation 
from test data on a limited number of species  to the real environment. Therefore, in  
EN 155   EN general, the more extensive the data and the longer the duration of the tests, the 
smaller is the degree of uncertainty a nd the size of the assessment factor. 
The specifications for the assessment factor s shall be elaborated in the notes for 
technical guidance which, to this end, shall be based particularly on the indications 
given in point 3.3.1 of Annex I to Regulation (EC) No. 1907/2006. 
41. For each environmental compartment an e xposure assessment shall be carried out in 
order to predict the concentration likely to be found of each active substance or 
substance of concern present in the biocidal product. Th is concentration is known as 
the predicted environmental concentration (PEC). However in some cases it may not 
be possible to establish a PEC and a qualitat ive estimate of exposure then has to be 
made. 
42. A PEC, or where necessary a qualitativ e estimate of exposure, need only be 
determined for the environmental compartments to which emissions, discharges, disposal or distributions including any rele vant contribution from  material treated 
with biocidal products are known or are reasonably foreseeable. 
43. The PEC, or qualitative estimation of expos ure, shall be determined taking account 
of, in particular, and if appropriate: 
– adequately measured exposure data, 
– the form in which the product is marketed, 
– the type of biocidal product, 
– the application method and application rate, 
– the physico-chemical properties, 
– breakdown/transformation products, 
– likely pathways to environmental compartments and potential for 
adsorption/desorption and degradation, 
– the frequency and duration of exposure. 
44. Where adequately measured, representati ve exposure data are available, special 
consideration shall be gi ven to them when conducting the exposure assessment. 
Where calculation methods are used for the estimation of exposure levels, adequate 
models shall be applied. The characteristics of  these models shall be as listed in point 
32. Where appropriate, on a case-by-case basi s, relevant monitoring data from 
substances with analogous use and exposur e patterns or analogous properties should 
also be considered. 
45. For any given environmental compartment, th e risk characterisation shall, as far as 
possible, entail comparison of the PEC w ith the PNEC so that a PEC/PNEC ratio 
may be derived.  
EN 156   EN 46. If it has not been possible to derive a PE C/PNEC ratio, the risk characterisation shall 
entail a qualitative evaluation of the likelihood that an effect is occurring under the current conditions of exposure or will occur under the expected conditions of 
exposure. 
Unacceptable effects 
47. Data shall be submitted to and evaluated by the competent authorities to assess 
whether the biocidal product does not cause unnecessary suffering in its effect on 
target vertebrates. This shall include an  evaluation of the m echanism by which the 
effect is obtained and the observed effects on the behaviour and health of the target 
vertebrates; where the intended effect is to kill the target vertebrate the time necessary to obtain the death of the target vertebrate a nd the conditions under which 
death occurs shall be evaluated. 
48. The competent authorities shall, where re levant, evaluate the possibility of the 
development of resistance to an active substa nce in the biocidal product by the target 
organism. 
49. If there are indications that any other unacceptable effects may occur the competent 
authorities shall evaluate the possibility of such effects occurring. An example of 
such an unacceptable effect would be an adverse reaction to fastenings and fittings 
used in wood following the application of a wood preservative. 
Efficacy 
50. Data shall be submitted and evaluated to ascertain if the efficacy claims of the 
biocidal product can be substantiated. Data submitted by the applicant or held by the competent authorities or the Agency must be  able to demonstrate the efficacy of the 
biocidal product against the target organism  when used normally in accordance with 
the conditions of authorisation. 
51. Testing should be carried out accordi ng to Community guidelines if these are 
available and applicable. Wher e appropriate, other methods can be used as shown in 
the list below. If relevant acceptable field data exist, these can be used. 
– ISO, CEN or other international standard method 
– national standard method 
– industry standard method (accepted by co mpetent authorities or the Agency) 
– individual producer standard method (ac cepted by competent authorities or the 
Agency) 
– data from the actual development of the biocidal product (accepted by 
competent authorities or the Agency). 
Summary 
52. In each of the areas where risk assessment s have been carried out, i.e. effects on man, 
animals, and the environment, the competen t authorities shall combine the results for  
EN 157   EN the active substance together with the results for any substance of concern to produce 
an overall assessment for the bi ocidal product itself. This should take account of any 
likely synergistic effects of th e active substance(s) and su bstances of concern in the 
biocidal product. 
53. For biocidal products contai ning more than one active s ubstance any adverse effects 
shall also be combined to produce an overall  effect for the biocidal product itself. 
DECISION  MAKING   
General principles 
54. Subject to point 90, the competent author ities or the Commission shall come to a 
decision regarding the authorisation for use of a biocidal product as a result of the 
integration of the risks arising from each active substance together with the risks 
from each substance of concern present in the biocidal product. The risk assessments 
shall cover normal use of the biocidal produ ct together with a realistic worst-case 
scenario including any relevant disposal issue either of the biocidal product itself or 
any material treated with it. 
55. In making a decision concerning authoris ation, the competent authorities or the 
Commission shall arrive at one of the fo llowing conclusions for each product type 
and for each area of use of the biocidal pr oduct for which application has been made: 
(1) the biocidal product cannot be authorised; (2) the biocidal product can be authorised subject to specific 
conditions/restrictions; 
(3) more data is required before a de cision on authorisation can be made. 
56. If the conclusion arrived at  by the competent authorities or the Commission is that 
additional information or data  are required before an auth orisation decision can be 
made, then the need for any such information or data shall be justified. This additional information or data shall be th e minimum necessary to carry out a further 
appropriate risk assessment. 
57. The competent authorities or the Commissi on shall only grant authorisation to those 
biocidal products which, when used accordi ng to their conditions of authorisation, do 
not present an unacceptable risk to hum ans, animals or the environment, are 
efficacious and which contain active substan ces permitted at Community level to be 
used in such biocidal products. 
58. The competent authorities or the Comm ission shall impose, where appropriate, 
conditions or restrictions when giving auth orisations. The nature and severity of 
these shall be selected on the basis of, and be appropriate to, the nature and extent of 
the expected advantages and the risks likel y to arise from the use of the biocidal 
product. 
59. In the decision-making process the compet ent authorities or the Commission shall 
take into consideration the following:  
EN 158   EN – the results of the risk assessment, in  particular the relationship between 
exposure and effect, 
– the nature and severi ty of the effect, 
– the risk management which can be applied, 
– the field of use of the biocidal product, 
– the efficacy of the biocidal product, 
– the physical properties of the biocidal product, 
– the benefits of using the biocidal product. 
60. The competent authorities or the Comm ission shall, when taking a decision 
concerning the authorisation of a biocidal product, take into account the uncertainty 
arising from the variability in the data used in the evaluation and decision-making 
process. 
61. The competent authorities or the Commissi on shall prescribe that biocidal products 
shall be used properly. Proper use shall include application at an efficacious dose and 
minimisation of use of biocidal products where possible. 
Effects on humans 
62. The competent authorities or the Commission shall not authorise a biocidal product if 
the risk assessment confirms that, in fore seeable application including a realistic 
worst possible scenario, the product presents an unacceptable risk to humans. 
63. The competent authorities or the Commi ssion shall consider pos sible effects on all 
human populations, namely professional us ers, non-professional users and humans 
exposed directly or indir ectly through the environmen t when making a decision on 
the authorisation of a biocidal product. 
64. The competent authorities or the Commissi on shall examine the relationship between 
the exposure and the effect, and use this  in the decision-making process. A number 
of factors need to be considered when examining this relationship and one of the 
most important is the nature of the adverse effect of the substance. These effects include acute toxicity, irritancy, corrosiv ity, sensitisation, repeat ed dose toxicity, 
mutagenicity, carcinogenicity, neurotoxicit y, reproduction toxicity together with 
physico-chemical properties, and any other adverse properties of the active substance 
or substance of concern. 
65. The competent authorities or the Commi ssion shall, where possible, compare the 
results obtained with those obtained from pr evious risk assessments for an identical 
or similar adverse effect and decide on an appropriate margin of safety (MOS) when 
making an authorisation decision. 
66. An appropriate MOS is typi cally 100 but an MOS higher or  lower than this may be 
appropriate depending on, among other things, th e nature of the critical toxicological 
effect.  
EN 159   EN 67. The competent authorities or the Commi ssion shall, if appropriate, impose, as a 
condition of authorisation, the wearing of personal protective equipment such as 
respirators, breathing-masks, overalls, gloves and goggles in order to reduce 
exposure for professional operators. Such equipment must be readily available to 
them. 
68. If for non-professional users the wearing of personal prot ective equipment would be 
the only possible method for reducing exposure, the product shall not normally be authorised. 
69. If the relationship between the exposure and the effect cannot be reduced to an 
acceptable level then no authorisation can be given by the competent authorities or the Commission for the biocidal product. 
Effects on animals 
70. The competent authorities or the Commission shall not authorise a biocidal product if 
the risk assessment confirms that, in norma l use, the biocidal product presents an 
unacceptable risk to non-target animals. 
71. Using the same relevant criteria as descri bed in the section dealing with effects on 
humans, the competent authorities or the Commission shall consider the risks posed 
to animals from the biocidal product when making an authorisation decision. 
Effects on the environment 
72. The competent authorities or the Commission shall not authorise a biocidal product if 
the risk assessment confirms that the active substance, or  any substance of concern, 
or any degradation, or reaction product pres ents an unacceptable risk in any of the 
environmental compartments, water (includi ng sediment), soil and air. This shall 
include the assessment of risks to non-t arget organisms in these compartments. 
In considering whether there is an unaccep table risk competent authorities or the 
Commission shall, when coming to a final de cision in accordance with point 90, take 
into account the crite ria in points 75 to 85. 
73. The basic tool used in the decision making is the PEC/PNEC ratio or, if this is not 
available, a qualitative estimation. Due cons ideration shall be gi ven to the accuracy 
of this ratio due to variability in the data used both in measurements of concentration 
and of estimation. 
In the determination of the PEC the most appropriate model should be used taking 
into account the environmental fate and behaviour of the biocidal product. 
74. For any given environmental compartment if the PEC/PNEC ratio is  equal to or less 
than 1 the risk characterisation shall be th at no further information and/or testing are 
necessary. 
If the PEC/PNEC ratio is greater than 1 the competent authorities or the Commission 
shall judge, on the basis of the size of that  ratio and on other re levant factors, if 
further information and/or testing are requi red to clarify the concern or if risk  
EN 160   EN reduction measures are necessary or if the product cannot be given an authorisation 
at all. Relevant factors to be considered  are those previously mentioned in point 37. 
Water 
75. The competent authorities or the Commissi on shall not authorise a biocidal product, 
if under the proposed conditions of use, th e foreseeable concentration of the active 
substance or of any other substance of concern or of relevant metabolites or breakdown or reaction products in water (o r its sediments) has an unacceptable 
impact on non-target species in the aquatic,  marine or estuarine environment unless it 
is scientifically demonstr ated that under relevant fi eld conditions there is no 
unacceptable effect. 
76. The competent authorities or the Commissi on shall not authorise a biocidal product 
if, under the proposed conditions of use, th e foreseeable concentration of the active 
substance or of any other substance of concern or of relevant metabolites or breakdown or reaction products  in groundwater exceeds the lower of the following 
concentrations: 
– the maximum permissible concentrati on laid down by Di rective 80/778/EEC 
relating to the quality of water intended for human consumption
60, or 
– the maximum concentration as laid dow n following the procedure for including 
the active substance in Anne x I to this Regulation, on the basis of appropriate 
data, in particular toxicological data 
unless it is scientifically demonstrated that under releva nt field conditions the lower 
concentration is not exceeded. 
77. The competent authorities or the Commission shall not authorise a biocidal product if 
the foreseeable concentration of the active substance or a substance of concern or of 
relevant metabolites, breakdown or reaction pr oducts to be expected in surface water 
or its sediments after use of the biocid al product under the proposed conditions of 
use: 
– exceeds, where the surface water in or from the area of envisaged use is 
intended for the abstraction of dr inking water, the values fixed by 
– Council Directive 75/440/EEC con cerning the quality required of 
surface water intended for the abstraction of drinking water in the Member States
61, 
– Directive 80/778/EEC or 
– has an impact deemed unacceptable on non-target species 
unless it is scientifically demonstrated that under relevant field conditions this 
concentration is not exceeded. 
                                                 
60 OJ L 229, 30.8.1980, p. 11. 
61 OJ L 194, 25.7.1975, p. 26.  
EN 161   EN 78. The proposed instructions for use of the biocidal product, including procedures for 
cleaning application equipmen t, must be such that th e likelihood of accidental 
contamination of water or its sediments is minimised. 
Soil 
79. Where unacceptable contamination of soil is likely to occur, the competent 
authorities or the Commission shall not au thorise a biocidal product if the active 
substance or substance of concern contained in it, after use of the biocidal product: 
– during tests in the field, persists in  soil for more than one year, or 
– during laboratory tests, forms non-extr actable residues in amounts exceeding 
70 % of the initial dose after 100 days with a mineralisa tion rate of less than 5 
% in 100 days, 
– has unacceptable consequences or effects on non-target organisms, 
unless it is scientifically demonstrated that under field conditions there is no 
unacceptable accumulation in soil. 
Air 
80. The competent authorities or the Commissi on shall not authorise a biocidal product 
where there is a foreseeable possibili ty of unacceptable effects on the air 
compartment unless it is scientifically demonstrated that under relevant field 
conditions there is no unacceptable effect. 
Effects on non-target organisms 
81. The competent authorities or the Commissi on shall not authorise a biocidal product 
where there is a reasonably foreseeable possibility of non-target organisms being exposed to the biocidal produc t if for any active substance or substance of concern: 
– the PEC/PNEC is above 1 unless it is clea rly established in the risk assessment 
that under field conditions no unacceptabl e effects occur after use of the 
biocidal product according to the proposed conditions of use, or 
– the bioconcentration factor (BCF) related to fat tissues in non -target vertebrates 
is above 1 unless it is clearly establishe d in the risk assessment that under field 
conditions no unacceptable effects occur, eith er directly or i ndirectly, after use 
of the product according to the proposed conditions of use. 
82. The competent authorities or the Commissi on shall not authorise a biocidal product 
where there is a reasonably foreseeable possibility of aquatic organisms including marine and estuarine organisms being expos ed to the biocidal product if for any 
active substance or substa nce of concern in it: 
– the PEC/PNEC is above 1 unless it is clea rly established in the risk assessment 
that under field conditions the viability  of aquatic organisms including marine 
and estuarine organisms is not threaten ed by the biocidal product according to 
the proposed conditions of use, or  
EN 162   EN – the bioconcentration factor (BCF) is gr eater than 1 000 for substances which 
are readily biodegrad able or greater than 100 for those which are not readily 
biodegradable unless it is clearly estab lished in the risk assessment that under 
field conditions no unacceptable impact, either  directly or indi rectly, occurs on 
the viability of exposed organisms incl uding marine and estuarine organisms 
after use of the biocidal product accord ing to the proposed conditions of use. 
83. The competent authorities or the Commissi on shall not authorise a biocidal product 
where there is a reasonably foreseeable possibility of micro-organisms in sewage treatment plants being exposed to the bioc idal product if for any active substance, 
substance of concern, relevant meta bolite, breakdown or reaction product the 
PEC/PNEC ratio is above 1 unle ss it is clearly established in the risk assessment that 
under field conditions no unacceptable impact, e ither directly or i ndirectly, occurs on 
the viability of such  micro-organisms. 
Unacceptable effects 
84. If the development of resistance to the active substance in th e biocidal product is 
likely the competent authorities or the Comm ission shall take steps to minimise the 
consequences of this resistance. This ma y involve modification of the conditions of 
authorisation or even refu sal of any authorisation. 
85. An authorisation for a biocidal product in tended to control vert ebrates shall not be 
given unless: 
– death is synchronous with the extinction of consciousness, or, 
– death occurs immediately, or, 
– vital functions are reduc ed gradually without signs of obvious suffering. 
For repellent products, the intended eff ect shall be obtained without unnecessary 
suffering and pain for the target vertebrate. 
Efficacy 
86. Competent authorities or the Commission shall not authorise a biocidal product 
which does not possess acceptable efficacy when used in accordance with the conditions specified on the proposed label or with other conditions  of authorisation. 
87. The level, consistency and duration of protection, contro l or other intended effects 
must, as a minimum, be similar to those resulting from suitable reference products, 
where such products exist, or to other m eans of control. Where no reference products 
exist, the biocidal product must give a de fined level of protecti on or control in the 
areas of proposed use. Conc lusions as to the performan ce of the biocidal product 
must be valid for all areas of proposed use and for all areas in the Member State or, 
where appropriate, in the Community, excep t where the biocidal product is intended 
for use in specific circumstances. Competent authorities shall evaluate dose response 
data generated in trials (which must in clude an untreated c ontrol) involving dose 
rates lower than the recommended rate, in or der to assess if the recommended dose is 
the minimum necessary to achieve the desired effect.  
EN 163   EN Summary 
88. In each of the areas where risk assessments  have been carried out, i.e. effects on 
humans, animals, and the environment, the competent authorities or the Commission 
shall combine the conclusions arrived at fo r the active substance and the substances 
of concern to produce an ove rall conclusion for the bi ocidal product itself. A 
summary should also be made of the e fficacy assessment and of the unacceptable 
effects. 
The result shall be: – a summary of the effects of the biocidal product on humans, 
– a summary of the effects of th e biocidal product on animals, 
– a summary of the effects of the bi ocidal product on the environment, 
– a summary of the efficacy assessment, 
– a summary of the unacceptable effects. 
OVERALL
 INTEGRATION  OF CONCLUSIONS   
89. The competent authorities or the Co mmission shall combine the individual 
conclusions arrived at with regard to effects of the biocidal product on the three 
sectors namely, humans, animals and the environment to arrive at an overall 
conclusion for the global effect of the biocidal product. 
90. The competent authorities or the Commissi on shall then take due consideration of 
any relevant unacceptable e ffects, the efficacy of the biocidal product and the 
benefits of using the biocid al product before taking an authorisation de cision on the 
biocidal product. 
91. The competent authorities or the Commissi on shall ultimately decide whether or not 
the biocidal product can be au thorised and whether this au thorisation shall be subject 
to any restrictions or conditions in confor mity with this Annex and this Regulation.  
EN 164   EN APPENDIX 1  
 
CORRELATION TABLE  
This Regulation Directive 98/8/EC 
Article 1 Article 1.1 
Article 2 
2.1 2.2 2.3 2.4 2.5 2.6   
Article 1.2 Article 1.2 Article 1.3 Article 1.4 
Article 3 3.1 3.2   
Article 2.1 Article 2.2 
Article 4 4.1 4.2 4.3 4.4   
Article 10.1 Article 10.3 Article 10.2 Article 10.2 
Article 5 
   
  
Article 6 
6.1 6.2 6.3   
Article 11.1.a Article 11.1.a.i and ii   
Article 7 7.1 7.2 
7.3 
7.4 7.5 7.6   
Article 11.1.a  
Article 8 8.1 8.2 8.3 8.4 8.5  
Article 11.2 1
st subparagraph 
Article 11.2 2nd subparagraph 
Article 10.1 1st subparagraph 
 Article 11.4  
EN 165   EN 8.6 
 Article 11.3 
Article 9 
9.1 9.2 9.3 9.4 9.5   
 
Article 10 10.1 10.2   
 Article 10.4 
Article 11 11.1 11.2 11.3 
11.4 
11.5 11.6   
 
Article 12 12.1 12.2 12.3 12.4 12.5 12.6 12.7   
Article 13 
13.1 13.2 13.3   
Article 10.4  
Article 14 
  
 
Article 15 
15.1 15.2 15.3 15.4 15.5   
Article 3.1 Article 8.1 Article 3.4 Article 3.6 Article 3.7 
Article 16 16.1 16.2 16.3  
Article 5.1 Article 5.1.b   
EN 166   EN 16.4 
16.5 16.6   
Article 5.2 Article 2.1.j 
Article 17 17.1 17.2 17.3 17.4   
Article 2.1.b 
Article 18 18.1 18.2 18.3 18.4 18.5   
Article 8.2  Article 8.12  Article 33  
Article 19 19.1 19.2   
 
Article 20 20.1 20.2 20.3   
Article 5.3 
Article 21 21.1 21.2 21.3 21.4 21.5 21.6   
  Article 10.5.i   Article 10.5.iii   
Article 22 22.1 22.2 22.3   
Article 23 
23.1 23.2 23.3 23.4 23.5 23.6   
Article 3.3.i    
Article 24 24.1  
  
EN 167   EN 24.2 
24.3 24.4 24.5 24.6 24.7 24.8 24.9  Article 3.6 
     Article 3.6  
Article 25 25.1 25.2 25.3 25.4 25.5 25.6   
Article 4.1 Article 4.1  Article 4.1 
Article 26 26.1 26.2 26.3 26.4   
Article 27 
27.1 27.2   
Article 4.4 Article 4.5 
Article 28 28.1 28.2 28.3 28.4 28.5 28.6 
28.7 
28.8 28.9 28.10   
Article 29 
29.1 29.2   
Article 4.2 
Article 30 30.1 30.2   
Article 31 
 Article 4.6 
Article 32   
EN 168   EN  
Article 33 
33.1 33.2   
Article 34 
34.1 34.2 34.3 34.4 34.5   
Article 35 
35.1 35.2 35.3 35.4 
35.5 
35.6   
 
Article 36 36.1 36.2 36.3 36.4 36.5 36.6 36.7 36.8   
 
Article 37 37.1 37.2 37.3 37.4 37.5 37.6   
  
Article 38 38.1 38.2 38.3   
Article 14.1  Article 14.2 
Article 39 39.1 39.2 39.3 39.4    
Article 7.1 Article 7.3  
Article 40 Article 7.2  
EN 169   EN  
Article 41 
 Article 7.5 
Article 42 
  
Article 43  
  
 
Article 44 44.1 44.2 44.3 44.4 44.5 44.6 44.7 44.8 44.9   
 
Article 45 45.1 45.2 45.3  
Article 15.1 Article 15.2  
Article 46 46.1 46.2 46.3 46.4  
Article 17.1 Article 17.2 Article 17.3 Article 17.5 
Article 47 47.1 47.2  
Article 48 
48.1 48.2 48.3 48.4 48.5  
Article 12.1    Article 12.3  
Article 49 49.1 49.2  49.3 49.4  
 Article 12.1.c.ii and 1.b and 1.d.ii Article 12.2.c.i and ii  
Article 50 50.1 50.2  
Article 51 
51.1 51.2  
Article 52   
EN 170   EN 52.1 
52.2 52.3 52.4 52.5 Article 13.2 
Article 53 
53.1 53.2  
Article 13.1  
Article 54 54.1 54.2 54.3 54.4  
Article 24  Article 24  
Article 55 55.1 55.2 55.3 
55.4  
  Article 19.1 
Article 19.2 
Article 56 
56.1 56.2 56.3  
Article 57 
57.1 57.2  
Article 58 
58.1 58.2 58.3  
Article 20.1 and 2 Article 20.3 Article 20.6 
Article 59 Article 21 2nd subparagraph 
Article 60 60.1 60.2 60.3 60.4 60.5  
Article 61 
61.1 61.2  
Article 62 
62.1 62.2 62.3  
Article 22.1 1
st and 2nd subparagraphs 
Article 22.1 3rd subparagraph 
Article 22.2 
Article 63 63.1 63.2 63.3  
Article 23 1
st subparagraph 
Article 23 2nd subparagraph 
 
Article 64  
Article 65 65.1   
EN 171   EN 65.2 
Article 66 
66.1 66.2 66.3  
Article 67 
67.1 67.2  
Article 68 
68.1 68.2  
Article 69  
Article 70 
70.1 70.2 70.3 70.4  
  Article 25 
Article 71 71.1 71.2  
Article 26.1 and 2 
Article 72 72.1 72.2 72.3 72.4 72.5  
Article 28.1  Article 28.3 Article 28.4 
Article 73 Articles 29 and 30 
Article 74   
Article 75   
Article 76  Article 32 
Article 77 77.1 77.2 77.3 77.4  
Article 16.2 Article 16.1 Article 16.3 
Article 78 78.1 78.2  
Article 79  
Article 80 
80.1 80.2  
Article 81  
Article 82 
82.1 82.2  
Article 83  
Article 84  
Article 85   
EN 172   EN Annex I Annex I 
Annex II Annex II A, III A and IV A 
Annex III Annex II B, III B and IV B 
Annex IV  
Annex V Annex V 
Annex VI Annex VI 
  
  
EN 173   EN APPENDIX 2  
 
LEGISLATIVE FINANCIAL STATEMENT  
1. NAME  OF THE  PROPOSAL: 
Proposal for a regulation of the European Pa rliament and of the Council concerning the 
placing on the market and use of biocidal products. 
2. ABM  / ABB  FRAMEWORK 
Policy area: 07 Environment 
Activity Code 07 03: Implementation of  Community environmental policy and 
legislation 
3. BUDGET  LINES 
3.1. Budget lines (operational lines and related technical and administrative 
assistance lines (ex- B..A lines)) including headings: 
NEW BUDGET LINE TO BE CREATED UNDER TI TLE 07 ENVIRONMENT – 
Chemicals Agency – activities in  the field of the Le gislation on Biocidal  Products — Subsidy 
under Titles 1 &2 
NEW BUDGET LINE TO BE CREATED UNDER TI TLE 07 ENVIRONMENT – 
Chemicals Agency – activities in  the field of the Le gislation on Biocidal  Products — Subsidy 
under Title 3 
The new budget lines to be created will cover ECHA’s staff and administrative expenditure 
(titles 1 and 2) and ECHA's opera ting expenditure (title 3) for th e activities to be carried out 
in the field of biocidal products in accordance with this Regulation, as part of the annual 
subsidy to the European Chemicals Agency (E CHA) from the Communi ty budget (in addition 
to the appropriations under budget items 02 03 03 01 and 02 03 03 02 to finance the activities 
of the REACH Regulation62). 
3.2. Duration of the action a nd of the financial impact: 
The duration of the action is not limited in time as the pr oposal establishes the rules 
applicable to the placing on the market of bioc idal products. The financ ial impact is, however, 
expected to be limited to supporting the Eur opean Chemicals Agency (ECHA) in taking up 
the additional tasks related to the assessment of  active substances used in biocidal products 
and of certain biocidal products . ECHA will indeed receive from industry specific fees for 
certain of these activities as well as an annua l fee for products authorised by the Community. 
                                                 
62 Regulation (EC) N° 1907/2006  
EN 174   EN It is expected that ECHA will be involved in  these tasks from the year 2012. As 2013 is the 
last year of the current financial programmi ng, estimates of the commitment and payment 
appropriations have been limited to that of  2012 and 2013 in this financial statement.  
A detailed analysis of the ECHA budget for thes e additional tasks is pr ovided in annexes to 
the financial statement for the years 2012 and 2013 as well as for the next 8 following years 
(i.e. until 2021), in order to match the timetable  attached to the REACH revised legislative 
Financial Statement (SEC(2006)924). 
3.3. Budgetary characteristics: 
Budget 
line Type of expenditure New EFTA 
contribution Contributions 
from applicant 
countries Heading in 
financial 
perspective 
NEW Non-
comp Diff YES YES NO No 2 
NEW Non-
comp Diff YES YES NO No 2  
EN 175   EN 4. SUMMARY  OF RESOURCES 
4.1. Financial Resources 
4.1.1. Summary of commitment appropriations (CA) and payment appropriations (PA) 
EUR million (to 3 decimal places) 
  
Expenditure type Section 
no.   
2012  
2013  
201463  
2015  
2016 2017 
and later  
Total 
  Operational expenditure          
  Commitment Appropriations 
(CA) 8.1. a 1,023 2,280     3,303 
  Payment Appropriations 
(PA)  b 1,023 2,280     3,303 
  Administrative expenditure wi thin reference amount     
  Technical & administrative 
assistance (NDA) 8.2.4. c - - - - - - - 
  TOTAL REFERENCE AMOUNT        
  Commitment 
Appropriations  a+c 1,023 2,280     3,303 
 Payment Appropriations  b+c 1,023 2,280     3,303 
  Administrative expenditure not  included in reference amount    
  Human resources and 
associated expenditure 
(NDA) 8.2.5. d - - - - - - - 
  Administrative costs, other 
than human resources and associated costs, not 
included in reference 
amount (NDA) 8.2.6. e 0,204 0,204 - - - - 0,408 
  Total indicative financial cost of intervention 
 TOTAL CA including cost 
of Human Resources  a+c+d
+e 1,227 2,484     3,711 
 TOTAL PA including cost 
of Human Resources  b+c+d
+e 1,227 2,484     3,711 
                                                 
63 Estimates of the commitment and payment appropriations are limited to the current financial 
programming running until 2013.   
EN 176   EN 4.1.2. Compatibility with Financial Programming 
 Proposal is compatible with existing financial programming. 
X Proposal will entail reprogramming of the relevant heading in the financial 
perspective (1,227M€ in 2012 and 2,484M€ in 2013). 
 Proposal may require application of th e provisions of th e Interinstitutional 
Agreement64 (i.e. flexibility instrument or re vision of the financial perspective). 
4.1.3. Financial impact on Revenue 
X Proposal has no financial implications on revenue 
There is no impact on the revenue side of the Community budget. ECHA's budget 
foresees its own revenues consisting of th e fees paid by industry, which ECHA is 
authorised to collect by virtue of the tasks entrusted to it under this Regulation and a 
balancing subsidy from the Community budget. 
For tasks related to biocidal products, the proposal foresees that  ECHA would charge 
fees for the inclusion and re newal of inclusion of active substances in Annex I, for 
the evaluation of application for the author isation, modification of  authorisation and 
renewal of authorisation of cer tain biocidal products at the Community level, as well 
as an annual fee to be paid by hol ders of Community  authorisations. 
Although the activities relating to  inclusion of active substa nces and authorisation of 
biocidal products are expect ed to be self-financed after a few years, a balancing 
subsidy from the Community budget could still be necessary, if the fee structure does 
not cover the expenses. The present financial fiche has been established with the hypothesis that some tasks woul d not be covered by the fees: 
– Preparation of opinions on questions refe rred to ECHA by virtue of Article 30 
of the proposal, in case of disagr eement between Member States during a 
mutual recognition procedure 
– Tasks related to data sharing and confidentiality 
– Development of general and specific guidance documents 
– Completion of Review Program me for existing substances 
– Reductions for SMEs (as proposed in point (a) of Article 70(2)) 
– Other tasks of Community inte rest not covered by fees 
Also, Article 68 of the proposal require s a clear separation of ECHA's budget 
between activities to be car ried out in accordance with the provisions of the REACH 
Regulation and the new and additional ta sks derived from this proposal. As a 
consequence, expenditures and revenues unde r these additional tasks have to be 
clearly identified by the account ing system of the agency. 
                                                
 
64 See points 19 and 24 of the Interinstitutional agreement.  
EN 177   EN 4.2. Human Resources FTE (including official s, temporary and external staff) – see 
detail under point 8.2.1. 
Annual requirements  
2012  
2013  
2014  
2015  
2016  
2017 
and 
later 
Total number of human 
resources - - - - - - 
5. CHARACTERISTICS  AND  OBJECTIVES 
5.1. Needs to be met in the short or long term 
Before any substance can be authorised for us e in a biocidal product, it must be assessed 
whether its use poses any unacceptable risk for the environment or public health. This 
assessment is done by Member State compet ent authorities followed by a peer review 
organised at the Community level, before a decision is taken by the Commission. 
In addition, to improve the authorisation proces s of biocidal products as well as to promote 
innovation and the development of new products w ith better health or environmental profile, 
it is proposed that certain pr oducts – those containing new active substances or those 
presenting a low risk – will be authorised direct ly at the Community level at the choice of the 
applicant. Other categories of biocidal product s will continue being authorised at Member 
State level. 
Also, for biocidal products to be authoris ed by the Member States, through the mutual 
recognition procedure, divergen ce of opinions between Member  States will need to be 
addressed through an ad hoc conflict resolution procedure. Most of these divergences of 
opinions are expected to be of a scientific or a technical nature. 
Last, genuine scientific and technical support for the implementation of the Regulation will 
need to be provided. 
5.2. Value-added of Community involvement and coherence of the proposal with 
other financial instrume nts and possible synergy 
Until today the Commission Joint Research Centre  provides a significant input to the review 
programme of existing active substances65. However, with the downsizing of its activities in 
                                                 
65 The current Directive 98/8/EC prov ides for the systematic evaluation of active substances, which were 
already on the market on 14 May 20 00, when that Directive came into force. This evaluation is carried 
out by Member States, which have all been allocated  a number of substances for which they have to 
produce assessment reports. These assessment report s are then peer reviewed by the other Member 
States and discussed at different meetings organised by the Commission JRC for the scientific and 
technical issues and then by DG Environment for the final discussions before the final steps of the decision-making process are taken (Comitology procedure). The scientific and technical discussions 
and the preparatory work they en tail to read the reports and anal yse the different issues require  
EN 178   EN the field of chemical substances due to the tran sfer of many of these activities to ECHA, the 
Commission JRC already announced that it would also stop its activities in the field of 
biocidal products at the end of 2013 and w ould then concentrate on other priorities. 
As the Commission services will then no longer have the expertise and resources to address 
issues of scientific or techni cal nature linked to the evaluati on of active substances and the 
authorisation of biocidal produc ts, it was considered most a ppropriate to seek advice and 
support from an external body.  
Relying on an external body to carry out the risk assessment is also in line with the approach 
adopted in other sectors such as medicinal products, plant protecti on products, food, where 
there is a clear separation betw een risk assessment (carried out  by scientific bodies) and risk 
management (carried out by the Commission). 
Having excluded the possibility of  establishing a speci fic body to be in charge of the risk 
assessment of active substances and biocidal pr oducts, three existing bodi es were considered 
as possible candidates to provide this scientific and technical support in the field of biocides: 
– The European Agency for the Evaluation of Medicinal Products (EMEA), because 
the proposal to authorise ce rtain biocidal products at  the Community level is 
modelled upon the lines and pr inciples of what already exist since 1995 for medicinal 
products for veterinary and human use; 
– The European Food Safety Authority (EFSA), because Directive 98/8/EC is often 
referred to as the sister Di rective of Directive 91/414/EEC  regulating the placing on 
the market of plant protection products an d where EFSA is the official scientific 
body in charge of preparing opi nions for the Commission; and 
– The European Chemicals Agency (ECHA). 
Limited synergies can however be expected from  the first two options. On the other hand, the 
choice of ECHA is expected to create signific ant synergies, on the basis of the following 
considerations: 
– First and foremost, the evaluation of activ e substances used in  biocidal products 
follows many of the methodologies and prin ciples that also apply to chemical 
substances. Data requirements are similar and the risk assessment of these substances, notably when they have certain h azardous propertie s, is even of  the direct 
competence of ECHA. 
– In addition, the proposal includes rules concer ning data sharing for biocidal products, 
which have now been aligned on those of  REACH and make mandatory the sharing 
of data involving testing on vertebrate animals. Only REACH and ECHA have already set up the mechanisms and the da tabases to make such sharing possible. 
– Last but not least, producers, downstream users of biocidal products and even the 
Commission already have a number of oblig ations under REACH. Notably, the data 
held by the Commission JRC relating to ac tive substances under evaluation in the 
                                                                                                                                                        
 
significant resources, which are cu rrently provided by the Commi ssion JRC and financed under the 
LIFE + programme under budget line 07 03 07.  
EN 179   EN review programme shall be made available to ECHA, in accordance with the 
provision of Article 16 of  the REACH Regulation. 
– Another important element of choice is that many of the ECHA scientific staff is 
already familiar with biocid al products, through previo us work at the Commission 
JRC, in Member States Competent Authorities as well as in industry. 
For these reasons, it is felt that  the ECHA, amongst the other options at hand - a new agency, 
the Commission JRC, the EMEA or EFSA - consider ed at an early stage of the process is the 
most effective one in terms of possible synergies. 
In addition, with the phasi ng out of the Commission JRC s upport concerning the review 
programme of existing active substances announ ced for the end of 2013, ECHA is expected to 
take over that role  from 2014 onwards.  
The legislative proposal therefore relies on th e assumption that a number of tasks of a 
scientific and technical nature related to the assessment of active substances used in biocidal products and of certain biocidal pr oducts will be given to ECHA. 
To this end, financial resources are needed to  ensure that ECHA has the appropriate level of 
staff and is able to convene as many meetings  as necessary to deliver its opinions to the 
Commission.  
EN 180   EN 5.3. Objectives, expected result s and related indicators of the proposal in the context 
of the ABM framework 
The objectives of the proposal are to ensure a hi gh level of protection of  public health and the 
environment as well as the harmonisation of th e internal market for biocidal products, while 
enhancing competitiveness and innovation. 
To achieve these objectives it is necessary that  the hazards and risks from active substances 
and biocidal products are fully known before they are placed on the market. 
To ensure the efficient implementation of the pr oposal it is appropriate to rely on the existing 
European Chemicals Agency, which will receive and deliver opinions on data submitted by industry, for example, for the evaluation of activ e substances or certain biocidal products, and 
will be the focal point for providing scientific  advice and assistance to the Commission, to 
Member State competent authorities, to enterprise s, especially SMEs, and for making relevant 
information available to the public. 
The harmonisation of the internal market fo r biocidal products and the enhancement of 
competitiveness and innovation will be strengthen by having a coherent approach to the treatment of applications submitted by industry, by simplifying procedures for the authorisation of products, and by encouraging the developmen t of ‘new’ substances and 
products having a better public hea lth or environmental profile, so  as to enable Europe to 
compete better with its internat ional competitors, and bring about  the greater availability of 
substances or products with lower risks. 
The objectives and indicators identified to date are as follows: 
Objectives Indicators for the policy 
Assessment of new active substances in view of their 
inclusion in Annex I of the Regulation Number of opinions delivered. 
Time from reception of a valid application to 
transmission of opinion to the Commission. 
Renewal of Annex I inclusion Number of opinions delivered. 
Time from reception of a valid application to 
transmission of opinion to the Commission. 
Authorisations of low-risk products Number of opinions delivered. 
Time from reception of a valid application to 
transmission of opinion to the Commission. 
Authorisations of products containing new active 
substances Number of opinions delivered. 
Time from reception of a valid application to 
transmission of opinion to the Commission. 
Opinion in case of disagreement during mutual 
recognition procedures Number of opinions delivered. 
Time from reception of a Commission request to 
transmission of opinion to the Commission. 
Tasks related to data sharing and confidentia lity Number of searches in the database. 
Number of request for information for non-confidential 
data. 
Development of general and specific guidance 
documents Number of guidance documents developed.  
EN 181   EN Maintenance of Community register on biocidal 
products Number of searches in the database 
Completion of the review programme of existing 
substances Number of opinions delivered. 
Time from reception of a dr aft Competent authority 
report to finalisation of Competent authority report. 
  
5.4. Method of Implementation (indicative) 
X Centralised Management 
X directly by the Commission 
X indirectly by delegation to: 
 executive Agencies 
X bodies set up by the Communities as referred to in art. 185 of the 
Financial Regulation 
 national public-sector bodies/bodies with public-service mission 
 Shared or decentralised management 
 with Member states 
 with Third countries 
 Joint management with internatio nal organisations (please specify) 
Relevant comments: 
The overall responsibility for the implem entation and enforcement of the proposed 
legislation will rest with the Commission services. However, the scientific and 
technical support will be provided by the European Chemicals Agency. ECHA will 
in particular have to provide opinions  on the level of risk presented by active 
substances used in biocidal products as well as on the authorisations of certain 
biocidal products. ECHA will only provide  opinions on the basis of which the 
Commission will take decisi ons (comitology procedure). 
6. MONITORING  AND  EVALUATION 
6.1. Monitoring system 
In order to evaluate the progress of impl ementation and effects of the new policy, the 
indicators as set out in 5.3 will be gathered a nd monitored at regular intervals. For the most 
part, this will be done as part of the normal activity of ECHA on an annual basis. 
In addition to this, Member States shall subm it to the Commission every three years a report on 
enforcement and control measures and results of these measures. T he Commission shall also  
EN 182   EN draw up a report on the implementation of the Re gulation and in particular on the functioning 
of the Community authorisation procedure and mutual recognition. 
6.2. Evaluation 
6.2.1. Ex-ante evaluation The Impact Assessment carried out by the Co mmission addresses five policy issues that 
require action: the extension of the scope of the Regulation to include articles and materials 
treated with biocidal products; the improvement of procedures for produ ct authorisation with 
the possibility to authorise cer tain products at the Community  level; the introduction of 
mandatory data-sharing at product authorisati on and active substance approval stage along the 
principles of the REACH Regulation; a clarific ation on data requirements with a combination 
of data waiving with the use of existing inform ation and a new approach for low-risk biocidal 
products; a partial harmonisation of  fee structure to encourage the development of more new 
active substances and the retention of more existing active substances. 
6.2.2. Measures taken following an intermediate/ex-post evalua tion (lessons learned from 
similar experiences in the past) 
The proposal is also based on the conclusions of a study carried out in 2007 to analyse the 
deficiencies of the current Directive. The results of this  study (available at 
http://ec.europa.eu/environment/biocides/study.htm
) were incorporated in the Commission 
report on the impacts of the implementati on of Directive 98/8/ EC (available at 
http://ec.europa.eu/environm ent/biocides/impl_report.htm ). 
6.2.3. Terms and frequency of future evaluation 
As indicated in Section 6.1 a ge neral report will be prepar ed by ECHA and submitted to the 
Commission. This information will be used by the Commission in order to prepare the report 
on the implementation of the Regulation. 
7. A NTI-FRAUD MEASURES  
The European Chemicals Agency has specific budgetary control mechanisms and procedures. 
These are however based on Regulation (EC, Euratom) No 2343/2002.  
The Management Board of ECHA, which compri ses representatives of the Member States, 
the Commission and the European Parliament (Article 79(1) of th e REACH Regulation), 
produces an estimate of the revenue and expendi ture of ECHA (Article 96(5)) and adopts the 
final budget (Article 96(9)). Each  year, the provisional and fina l accounts are sent to the 
European Court of Auditors (paragraphs 4 a nd 7 of Article 97). The European Parliament 
gives a discharge to the Di rector of ECHA rega rding the implemen tation of the budget 
(Article 97(10)).  
In order to combat fraud, corruption and ot her unlawful activities, the provisions of 
Regulation (EC) No 1073/1999 c oncerning investigations co nducted by the European Anti-
Fraud Office (OLAF) apply without restrictions to ECHA, in accordance with Article 98(1) of 
Regulation (EC) No 1907/2006. 
In accordance with Article 98(2), ECHA is also  bound by the Interinstitutional Agreement of 
May 25, 1999 concerning internal investigations  by the European Anti-Fraud Office (OLAF). 
EN 183   EN 8. DETAILS  OF RESOURCES 
8.1. Objectives of the proposal in  terms of their financial cost 
Commitment appropriations in EUR million (to 3 decimal places) 
Year 2012 Year 2013 Year 2014 Year 2015 Year 2016 Year 2017  and 
later TOTAL (Headings of 
Objectives, actions and 
outputs should be 
provided) Type of output Av. 
cost 
No. 
outputs Total 
cost No. 
outputs Total 
cost No. 
outputs Total 
cost No. 
outputs Total 
cost No. 
outputs Total 
cost No. 
outputs Total 
cost No. 
outputs Total 
cost 
OPERATIONAL OBJECTIVE 
No.1
1ECHA 
scientific and 
technical support Please refer to Annex 1 for a detailed breakdown of ECHA’s costs and to Annex 2 for the main underlying 
assumptions. 
TOTAL COST    1,023  2,280            
EN 184   EN 8.2. Administrative Expenditure 
8.2.1. Number and type of human resources 
Types of post  Staff to be assigned to management of the action using existing and/or 
additional resources ( number of posts/FTEs ) 
  Year 
2012 Year 
2013 Year 
2014 Year 
2015 Year 
2016 Year 
2017 
A*/AD - - - - - - Officials or 
temporary 
staff66 (XX 
01 01) B*, 
C*/AST - - - - - - 
Staff financed67 by art. 
XX 01 02 - - - - - - 
Other staff68 financed by 
art. XX 01 04/05 - - - - - - 
TOTAL - - - - - - 
  
No additional staff will be necessary. Add itional resources will however be required 
to cover participation in meetings held  in ECHA and for the organisation of an 
increased number of meetings of the Standing Committee on Biocidal Products (see 
8.2.6). 
8.2.2. Description of tasks deriving from the action 
Not applicable. 
8.2.3. Sources of human resources (statutory) 
 Posts currently allocated to the management of the programme to be replaced 
or extended 
 Posts pre-allocated within the APS/PDB exercise for year n 
 Posts to be requested in the next APS/PDB procedure 
 Posts to be redeployed using existi ng resources within the managing service 
(internal redeployment) 
 Posts required for year n although not fo reseen in the APS/PDB exercise of the 
year in question 
                                                 
66 Cost of which is NOT covered by the reference amount 
67 Cost of which is NOT covered by the reference amount 
68 Cost of which is included within the reference amount  
EN 185   EN 8.2.4. Other Administrative expenditure  included in reference amount (XX 01 04/05 – 
Expenditure on administrative management) 
EUR million (to 3 decimal places) 
Budget line 
(number and heading) Year 
2012 Year 
2013 Year 
2014 Year 
2015 Year 
2016 Year 
2017  
and 
later TOTAL 
1 Technical and administrative 
assistance (including related staff costs) - - - - - - - 
Executive agencies - - - - - - - 
Other technical and administrative 
assistance - - - - - - - 
 - intra muros   - - - - - - - 
 - extra muros - - - - - - - 
Total Technical and administrative 
assistance - - - - - - - 
8.2.5. Financial cost of human resources and associated costs not  included in the reference 
amount 
EUR million (to 3 decimal places) 
Type of human resources Year 
2012 Year 
2013 Year 
2014 Year 
2015 Year 
2016 Year 
2017  
and later 
Officials and temporary staff 
(XX 01 01) - - - - - - 
Staff financed by Art XX 01 
02 (auxiliary, END, contract staff, etc.) 
(specify budget line) - - - - - - 
Total cost of Human 
Resources and associated costs (NOT in reference 
amount) - - - - - - 
   
EN 186   EN 8.2.6. Other administrative expenditure not  included in reference amount 
EUR million (to 3 decimal places)
 Year 
2012 Year 
2013 Year 
2014 Year 
2015 Year 
2016 Year 
2017 
and 
later TOTAL 
07 01 02 11 01 – Missions 0,024 0,024     0,048 
07 01 02 11 02 – Meetings & Conferences - 0 - - - - 0 
07 01 02 11 03 – Committees  0,180 0,180 - - - - 0,360 
07 01 02 11 04 – Studies & consultations - 0 - - - -  
07 01 02 11 05 - Information systems - 0 - - - -  
2 Total Other Management 
Expenditure (XX 01 02 11) 0,204 0,204 - - - - 0,408 
3 Other expenditure of an 
administrative nature (specify 
including reference to budget line) - 0 - - - - 0 
Total Administrative expenditure, 
other than human resources and associated costs (NOT included in 
reference amount) 0,204 0,204 - - - - 0,408 
  
Calculation - Other administrative expenditure not  included in reference amount 
20 2-day missions to Agency per year at 1200 EUR per mission 
Standing Committee on Biocidal Products: 6 one-d ay meetings per year at 30.000 EUR/meeting 
  
The needs for human and administrative resources shall be covered within the allocation that 
can be granted to the managing DG in the framew ork of the annual alloca tion procedure in the 
light of budgetary constraints.  
EN 187   EN ANNEX 1  
Draft Budget for the European Chemicals Agency (in Euros)  
Tasks related to biocidal products  
  
  2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 
            
Expenditure            
            
Title1            
Salaries & allocations   578,600 1,959,800 3,680,700 4,240,600 4,157,700 4,157,700 4,032,400 4,320,800 4,358,000 4,285,900 
Other personnel costs  19,300 157,200 315,700 362,900 362,900 362,900 362,900 377,300 384,600 384,600 
            
Total Title 1   597,900 2,117,000 3,996,400 4,603,500 4,520,600 4,520,600 4,395,300 4,698,100 4,742,600 4,670,500 
            
            
Title 2            
Rental of building and associated costs   69,200 234,500 440,500 507,500 497,500 497,500 482,600 517,100 521,500 512,900 
Information & communication technology  23,800 80,700 151,500 174,500 171,100 171,100 166,000 177,800 179,400 176,400 
Movable property and associated costs  4,900 16,700 31,300 36,100 35,400 35,400 34,300 36,800 37,100 36,500 
Current administrative expenditure  4,900 16,500 30,900 35,600 34,900 34,900 33,900 36,300 36,600 36,000 
Postal charges and telecommunication  2,900 9,700 18,200 21,000 20,600 20,600 19,900 21,400 21,500 21,200 
Expenditure on meetings other than those covered under Title 3  400 1,400 2,600 3,000 2,900 2,900 2,800 3,100 3,100 3,000 
            
Total Title 2   106,100 359,500 675,000 777,700 762,400 762,400 739,500 792,500 799,200 786,000 
            
            
                      
Title 3                     
Development of databases and software 
tools related to the operation of biocidal 
products related activities  300,000 300,000 83,700 96,000 93,500 93,500 91,000 95,100 93,500 91,900 
Evaluation activities  2,100 7,900 15,200 17,500 17,000 17,000 16,600 17,300 17,000 16,700 
Information and publications  1,400 5,300 10,300 11,800 11,500 11,500 11,200 11,700 11,500 11,300 
Helpdesk services  8,000 29,600 57,100 65,500 63,800 63,800 62,000 64,800 63,700 62,700 
Studies and Consultants  1,600 5,900 11,400 13,100 12,800 12,800 12,400 13,000 12,700 12,500 
Mission expenses  3,500 12,800 24,700 28,300 27,600 27,600 26,900 28,100 27,600 27,100 
Technical training of staff and stakeholders  2,400 8,900 17,100 19,600 19,100 19,100 18,600 19,400 19,100 18,800 
Meetings of the Committee on biocidal products and subgroups  0 707,200 707,200 707,200 707,200 707,200 707,200 707,200 707,200 707,200 
Fees paid back to Ev aluating Member State  0 2,520,000 2,758,600 2,877,300 3,115,900 3,373,700 3,631,500 4,215,800 4,646,400 4,885,000 
Fees paid back to rapporteurs  0 326,000 328,400 324,800 327,200 330,400 333,600 350,400 360,800 363,200 
            
Total Title 3   319,000 3,923,600 4,013,700 4,161,100 4,395,600 4,656,600 4,911,000 5,522,800 5,959,500 6,196,400 
           
            
Total   1,023,000 6,400,100 8,685,100 9,542,300 9,678,600 9,939,600 10,045,800 11,013,400 11,501,300 11,652,900 
            
Revenues                      
           
Community subvention   1,023,000 2,280,100 3,941,100 4,294,300 3,806,600 3,411,600 2,861,800 2,629,400 2,173,300 1,700,900 
Fee income of agency  0 4,120,000 4,744,000 5,248,000 5,872,000 6,528,000 7,184,000 8,384,000 9,328,000 9,952,000 
Over income to next year   0 0 0 0 0 0 0 0 0 0 
           
Total   1,023,000 6,400,100 8,685,100 9,542,300 9,678,600 9,939,600 10,045,800 11,013,400 11,501,300 11,652,900  
EN 188   EN ANNEX 2  
 
Applied methodology and main underlying assu mptions for the fina ncial model of the 
European Chemicals Agency for ac tivities relating to biocides  
  
Computation of staff costs  
Due to the fact that the Commission JRC in Is pra currently has a major role in operating the 
review programme of substances used in bioc idal products establishe d by Directive 98/8/EC, 
significant experience exists with  regard to how long certain tasks take and what kind of 
resources are needed in order to carry them out (differentiation betw een different categories 
of staff). 
Based on this experience and on the model de veloped for the operation of REACH, a staff 
model has been developed for the operation of th e activities related to biocides. The output of 
this staff model is how many sta ff (by grade) are required in a gi ven year to fulfil the tasks of 
ECHA (operational tasks of th e biocides legislation).  
To these staff numbers additional resource requirements have been added for the management 
and training of these resources, taking into acco unt economies of scale that can be achieved in 
particular in support tasks and staff from existing arrangements set up for the implementation 
of the REACH Regulation (e.g. for internationa l relations, for external communication, 
helpdesk services, the Legal Department, Audit and Internal Control, Human Resources (HR), 
Finance, Information Technology (IT) Building Management). Based on the current ECHA 
staff ratio, these additional re sources amount to 20% of thos e required for the operational 
tasks related to the biocidal legislation. 
For the scientific staff, the ratio in % of AD and AST grades is in compliance with the 
REACH staff model. As is the case for sta ff carrying out REACH related tasks, a higher 
number of AD than AST staff is justified because  of the complexity of the scientific tasks. 
For 2012, it is proposed that ECHA should be able  to recruit staff to  prepare the grounds 
before the date when ECHA tasks relating to  biocidal products come into operation.  
From 2013, ECHA would then be responsible for th e different tasks set out in the proposal. 
From 2014, the responsibility of  coordinating the review progr amme of existing substances 
would be transferred from the Commission JRC to ECHA (cf. Article  71 of the proposal). 
ECHA would therefore need extra resources to carry out this additi onal task. Based on the 
current assumptions, ECHA would require 10 additional scientific officers to carry that task (3 of whom could already be r ecruited in the last quarter of 2013 to prepare the activities and 
ensure a smooth hand-over). However, as the re view programme is expected to be completed 
within 4 to 5 years afterwards, this additional ta sk could be carried out in part via contractual 
staff to limit the impact on the establishment plan. 
Annex 3 sets out the proposed establishment pl an related to this pr oposal. The budget set out 
in Annex 1 takes into account pe rmanent / temporary staff (i.e. that appear in  establishment 
plan) and contract agents (count for staff cost s but do not appear in establishment plan).  
EN 189   EN All the resources computed have been multiplied  by the average annual cost by grade and that 
has led to the total staff costs.  In addition, the weighting factor  for Helsinki (119.8% – cost of 
living adjustment applicable to  all staff) has been applied. 
The other personnel costs in Titl e 1 have been assumed to repr esent 10% of salary costs of 
permanent / temporary staff. 
  
Applied average costs for perma nent/temporary staff by gr ade per annum (source ECHA) 
Grade Salary 
AD 13 187,472 
AD 12 175,575 
AD 5-11 114,264 
AST 7-11 103,973 
AST 1-6 112,189 
 
Applied average costs for contract agents by function group per annum (source ECHA) 
Grade Salary 
FG IV 72,139 
FG III 52,674 
FG II 39,836 
FG I 34,747 
  
For the purpose of the computation of the staff required it has been assu med that per year the 
following resources would be needed: 
– a desk officer per 10 applicati ons for product authorisation; 
– a desk officer per 10 applicat ions for substance evaluation 
– a desk officer per 30 applications to amend an existing product authorisation 
– a desk officer per 20 opinions requested in case of disagreement during Mutual 
Recognition 
Computation of building, equipment a nd miscellaneous operating expenditure:  
All building, equipment, furnitu re, IT and other administrati ve expenditure have been 
computed based on the number of required staff multiplied by average cost figures per person based on the current Agency budget. 
Operating expenditure:
 
Major cost items in this area are general opera ting expenditures and all expenditure related to 
the Committee for Biocidal Products. 
The major cost driver for the general operat ing expenditure is the expenditure for the 
Committee for Biocidal Products and the fees pa id back to the Competent Authorities in 
charge of the scientific evaluation.  
EN 190   EN For the Committee for Biocidal Products and its experts groups, the costs include the 
reimbursement of travel, hotel, daily allo wances according to currently applicable 
Commission rates. 
It has also been assumed for the purpose of th e computation of ECHA expenses, that 60% and 
5% of the fee paid to ECHA would be paid back to the Competent Authorities and the 
Rapporteur in charge of the scie ntific evaluati on respectively. 
This represents only an hypothesis and is therefore provisional a nd without prejudice to 
ECHA’s decision in this matter. 
Computation of expected fee income:  
It is assumed that ECHA will have a very simple  fee structure for tasks related to biocidal 
products.  
For the purpose of the computation of the e xpected fee income it has been assumed that: 
– Fees for inclusion of an active substance in Annex I amount to EUR 400,000 
– Fees for renewal of Annex I inclus ion amount to EUR 40,000 when a thorough 
evaluation is required but can be reduced  to 10,000 when this is not the case. 
– Fees for product authorisation amount  to EUR 100,000 for products containing new 
active substances, to EUR 80,000 for low-risk products. 
– Annual fees amount to EUR 20,000 
The amounts of fees above were calculated on the basis of the average value of the fees 
charged by the Member States. 
As noted in the impact assessment, there are however differences in the structure and level of 
fees from one Member State to another:  
Fees charged for the evaluation of activ e substances vary from €10,000 to €356,000 per 
substance (Figure 1) 
Fees for the authorisation of biocidal products range from €626 to €85,500 per biocidal 
product (Figure 2).  
EN 191   EN 
 
Figure 1: Member States Fees and Fe e Ranges for Active Substance Evaluation 
(Fee in Thousand EURO – Vertical lin es indicate Member State Fee Ranges) 
 
Figure 2: Member States Fees and Fee Ranges for Product Authorisation 
(Fee in Thousand EURO – Vertical lin es indicate Member State Fee Ranges) 
These fees will however have to be estab lished by a separate Fee Regulation (Commission 
Regulation). In that context it will be necessary to establish the fee structure that allows certain reduction for SMEs as foreseen in the proposal.  
The rates of fees and the structure outlined  above represent only one hypothesis and are 
therefore provisional and without prejudice to the Commission’s decision in this matter. 
The corresponding revenues were calculated ba sed on a certain number of procedures per 
year. 
– Evaluation of new active substances: 5/year 
– Authorisation of products based on new active substances: 4/year  
EN 192   EN – Authorisation of low risk biocidal products: 20/year 
– Amendments of Community authoris ations: 0,5/year/pr oduct authorised.  
EN 193   EN ANNEX 3  
ESTABLISHMENT PLAN  
Additional staff to carry out activi ties related to biocidal products  
  
 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 
           
AD 13 0 1 1 1 1 1 1 1 1 1 
AD 12 1 2 3 3 3 3 3 3 3 3 
AD 5-11 1 8 15 15 15 15 15 15 15 15 
AST 7-11 0 3 4 4 4 4 4 5 5 5 
AST 1-6 0 4 7 7 7 7 7 8 8 8 
                     
Overall 2 18 30 30 30 30 30 32 32 32